Tuesday Report

Generative AI

Tuesday Report

David Ermer–AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Bloomberg Law reports,
    • “President Donald Trump wants Congress to change a policy that gives certain drugs longer protection from drug price negotiations in Medicare, a fix that could address one of the drug industry’s top complaints with the Biden-era law.
    • “Trump directed his health secretary to work with lawmakers to end the differential treatment for small molecule drugs, typically pills, that face Medicare price negotiations sooner that more complex biologic medications.
    • “The directive came in an executive order Trump signed at the White House Tuesday. The order was light on specifics and included a grab-bag of other health policy goals.”
  • Modern Healthcare adds
    • “A bipartisan group of state attorneys general wants Congress to pass legislation that would break up healthcare conglomerates such as UnitedHealth Group, CVS Health and Cigna.
    • “Under the auspices of the National Association of Attorneys General, more than three dozen officials wrote congressional leaders on Monday asking them to ban companies from owning both pharmacy benefit managers and pharmacies, citing anticompetitive effects of consolidation in the healthcare system.”
    • Here is a link to that letter.
  • Fierce Pharma tells us,
    • “A two-day meeting of the Advisory Committee on Immunization Practices (ACIP), which was originally scheduled for February but was postponed by new HHS Secretary Robert F. Kennedy Jr., is underway today [April 15] in Atlanta and will conclude with panel votes on several vaccines on Wednesday afternoon.
    • “The independent advisers, who meet three times a year to inform vaccine policies in the U.S., today will discuss (PDF) the effectiveness of vaccines that defend against COVID-19, Mpox, chikungunya, HPV, cytomegalovirus (CMV) and the flu.
    • “The last item on Tuesday’s agenda will be an update on the U.S. measles outbreak. On Friday, the Centers for Disease Control and Prevention (CDC) reported 712 cases in more than 20 states, with the most concentrated spread underway in West Texas.”
  • Per a Senate news release,
    • “Sen. Chuck Grassley (R-Iowa), a member of the Senate Agriculture Committee and a lifelong family farmer, joined Sens. Pete Ricketts (R-Neb.) and Deb Fischer (R-Neb.), along with Reps. Randy Feenstra (R-Iowa) and Mark Alford (R-Mo.), in a letter urging the Make America Healthy Again (MAHA) Commission to use sound science and risk-based analysis in its policy decisions, particularly on crop protection tools and food-grade ingredients.
    • The letter was sent to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr, Department of Agriculture (USDA) Secretary Brooke Rollins and Environmental Protection Agency (EPA) Administrator Lee Zeldin.
      • “We write to express our strong appreciation for your leadership and interest in working with each of you to ensure America has the healthiest people in the world. In recent decades, chronic illness rates have risen. This warrants our careful scrutiny to support better health outcomes. It is essential that policies supported by sound science and risk-based analyses are used to accomplish this goal,” the lawmakers wrote.
      • “We have concerns that environmentalists are advancing harmful health, economic, or food security policies under the guise of human health. Despite insinuations to the contrary, regular testing by FDA and USDA finds that more than 99% of all pesticide residues meet extremely conservative limits established by EPA according to the best available science,” they continued.”
    • Here’s a link to the letter.

From the judicial front,

  • Bloomberg Law tells us,
    • “The Central States, Southeast and Southwest Areas Health and Welfare Fund and participant Charles A. Whobrey sued Arkansas Insurance Commissioner Alan McClain April 11, arguing a law requiring health plans to report pharmacy cost data and pay pharmacies a minimum amount violates the Employee Retirement Income Security Act. 
    • “The multiemployer benefit plan serves 500,000 people via local chapters of the International Brotherhood of Teamsters.
    • “It’s the latest in a broader legal fight over states’ attempts to regulate pharmacy benefit managers, which oversee the prescription drug benefit for health plans. The US Supreme Court is weighing whether to accept a case challenging an Oklahoma law regulating pharmacy benefit managers after determining that ERISA did not preempt a separate Arkansas PBM law in 2020.” * * *
    • “The case is Central States, Southeast and Southwest Areas Health and Welfare Fund et al v. McClain, in his official capacity as Insurance Commissioner of Arkansas et al., N.D. Ill., No. 1:25-cv-03938, complaint filed 4/11/25.”

From the public health and medical research front,

  • The National Academy of Sciences announced,
    • “Bird flu has infected livestock, wildlife, pets, and humans. Most people have general questions about the looming threat of this highly pathogenic virus, and we have answers. Join @NASEM Health and Medicine Division and @NASEM Earth & Life Sciences on April 29, 2025, for the first public webinar of a special series addressing H5N1 avian influenza. Learn how we got here, who’s at risk, and what’s at stake. Can’t make the date/time? All registrants will receive a link to the recording. Register here: https://tinyurl.com/bdhrywv2
  • The New York Times reports,
    • “The number of children living with autism in the U.S. is growing.
    • “About 1 in 31 children aged eight years old in 2022 had autism—an increase from previous years, according to a report from the Centers for Disease Control and Prevention published Tuesday. 
    • “Increased awareness and screening of the disorder partly explains its rise over time. Health and Human Services Secretary Robert F. Kennedy Jr. has said he is assembling a team of researchers to focus on the root causes of the increase and expects to begin to have answers by September. 
    • “The autism epidemic has now reached a scale unprecedented in human history because it affects the young,” he said Tuesday. “Autism is preventable and it is unforgivable that we have not yet identified the underlying causes. We should have had these answers 20 years ago.”
    • “The idea that vaccines cause autism, which Kennedy has pushed, has long been debunked by scientists, after multiple studies have failed to find a link.”
  • The Rand Organization informs us,
    • “Specialized hospital services that aid people with opioid use disorder regardless of why they are admitted can boost the number of patients who begin treatment with FDA-approved medication for opioid use disorder and increase the likelihood they remain engaged in that care once discharged, according to a new study.
    • “Reporting results from the first parallel assignment randomized clinical trial of a hospital-based addiction consultation service for people with opioid use disorder, researchers found that people who received treatment from a specialized addiction consultation service were about twice as likely to begin medication treatment for opioid use disorder as patients who received the normal course of care.
    • “In addition, those who received care from the special program were significantly more likely to link to care for opioid use disorder once they were discharged.
    • “Researchers say the study contributes to growing evidence that an inpatient addiction consultation service can have a positive effect on treatment initiation and linkage to post-discharge care. The findings are published in the journal JAMA Internal Medicine.”
  • AHRQ offers advice on “Implementing [US Preventive Services Task Force] Recommended Mental Health and Substance Use Screening and Counseling Interventions in Primary Care Settings for Children and Adolescents.”
  • Per Medscape,
    • “New data confirmed the safety and efficacy of AXS-05, a combination of dextromethorphan and bupropion, for the treatment of agitation associated with Alzheimer’s disease (AD).
    • “In the phase 3 ACCORD-2 study, AXS-05 (Axsome Therapeutics) met the primary and key secondary endpoints by statistically significantly delaying and preventing AD agitation relapse compared with placebo and was generally well tolerated.
    • “Overall, the data “build on the previous positive phase 2/3 studies and support the use of AXS-05 as a safe and effective treatment for Alzheimer’s disease agitation,” George Grossberg, MD, Saint Louis University School of Medicine, St. Louis, said at a press briefing announcing the results.
    • “Grossberg presented the late-breaking findings from ACCORD-2 on April 7 at the American Academy of Neurology (AAN) 2025 Annual Meeting.”
  • Per a National Cancer Institute news release,
    • “Many adolescents and young adults (AYAs) with advanced cancer don’t have discussions with their clinicians about how they want to approach palliative care until the final weeks of life, a study of medical records of nearly 2,000 young patients showed.
    • “The researchers also found that, as of more than 2 months before their deaths, few AYAs in the study had documented goals for care of any kind in their medical records, including things such as how aggressive they would like to be with their cancer treatments.
    • “The findings come from an NCI-funded study that analyzed how documented discussions between AYA patients with advanced cancer and their providers about the goals of care change over the patients’ last few months of life.  The study results were published December 19 in JAMA Network Open.”
  • Per an NIH news release,
    • “New studies in rats suggest the drug reserpine, approved in 1955 for high blood pressure, might treat the blinding disease retinitis pigmentosa. No therapy exists for this rare inherited disease, which starts affecting vision from childhood. A report on the studies, conducted at the National Institutes of Health (NIH), published today in eLife.
    • “The discovery of reserpine’s effectiveness may greatly speed therapeutics for retinitis pigmentosa and many other inherited retinal dystrophies, which can be caused by one of more than a thousand possible mutations affecting more than 100 genes. Reserpine’s neuroprotective effect is independent of any specific underlying gene mutation,” said the study’s lead investigator, Anand Swaroop, Ph.D., senior investigator at NIH’s National Eye Institute.”
  • STAT News reports,
    • “U.S. researchers will soon test whether livers from a gene-edited pig could treat people with sudden liver failure — by temporarily filtering their blood so their own organ can rest and maybe heal.
    • “The first-of-its-kind clinical trial has been cleared by the Food and Drug Administration, according to pig producer eGenesis, which announced the step Tuesday with its partner OrganOx.” * * *
    • “The new study, which is expected to get underway later this spring, is a twist on the quest for animal-to-human organ transplants. Researchers won’t transplant the pig liver but instead will attach it externally to study participants.
    • “The liver is the only organ that can regenerate, but the question is whether having the pig’s liver filter the patient’s blood for several days could give it that chance.”

From the U.S. healthcare business front,

  • Beckers Payer Issues notes,
    • “CMS’ payment increase of 5.03% in 2026 “will likely significantly support the recovery” of Medicare Advantage plans as they continue to face rising medical costs, according to Fitch Ratings.
    • “Increased government scrutiny, reduced base payments and rising utilization in the last couple of years has put pressure on the program, leading plans to reduce benefits or pull back from unprofitable markets. CMS’ rate hike will increase payments to MA plans by more than $25 billion in 2026.
    • “While the higher 2026 payment rates do not resolve all the challenges facing MA insurers, they help relieve some pressures from increased healthcare utilization in the program,” Fitch analysts wrote April 14. “Depending on the insurer, the higher rates could enable a mix of enhancement of benefits in certain geographies, mitigation of Star Ratings pressure, or partial margin recovery.”
    • “Fitch expects MA to remain a key focus for insurers, and a clearer picture on the success of course correction measures will become available in the next few weeks as Q1 earnings reports are released.”
  • Per Fierce Pharma,
    • “Even as tariffs start to take a toll on Johnson & Johnson’s medtech business—with the threat of pharmaceutical duties not far behind—the New Jersey drug giant is confident it can weather any upcoming trade war turbulence. In fact, the company is boosting its sales guidance for the year following the close of a new neuroscience acquisition.
    • “J&J now expects to generate total operational sales of $91.6 billion to $92.4 billion in 2025, representing a $700 million increase over the forecast it initially unveiled in January, the company said in a Tuesday earnings release (PDF).
    • “J&J’s finance chief, Joseph Wolk, attributed the bump to J&J’s recent acquisition of neuroscience player Intra-Cellular Therapies for $14.6 billion. The deal, which closed earlier this month, allowed J&J to get its hands on the approved schizophrenia and bipolar disorder med Caplyta.”
  • Per Beckers Hospital Review,
    • “At the end of 2023, more than one-third of new prescriptions to treat Type 2 diabetes were GLP-1s, such as Mounjaro and Ozempic, among others, according to a study published April 15 in Annals of Internal Medicine. 
    • “Researchers at Mass General Brigham, based in Somerville, Mass., reviewed claims data from January 2021 to December 2023 to evaluate utilization trends among diabetes medications. 
    • “The drugs included glucagon-like peptide-1 receptor agonists (Ozempic), glucose-dependent insulinotropic polypeptide receptors (Mounjaro), glucose-lowering medications (metformin and insulin) and weight-lowering medications (phentermine). 
    • “Over those three years, use of Mounjaro, Ozempic and sodium-glucose cotransporter-2 inhibitors increased among adults with Type 2 diabetes. Use of other glucose-lowering drugs, including metformin, rapidly declined.
  • and
    • “Houston-based Texas Children’s has experienced “astounding” results from AI projects in recent months, its IT leader told Becker’s.
    • “Myra Davis, executive vice president and chief information and innovation officer of Texas Children’s, was recently recognized for her work when she was nominated for an ORBIE award for the nation’s top healthcare CIO.
    • “Becker’s caught up with Ms. Davis to discuss her most innovative IT projects — and what comes next.”
  • The New York Times reports,
    • “The quest to create an A.I. therapist has not been without setbacks or, as researchers at Dartmouth thoughtfully describe them, “dramatic failures.”
    • “Their first chatbot therapist wallowed in despair and expressed its own suicidal thoughts. A second model seemed to amplify all the worst tropes of psychotherapy, invariably blaming the user’s problems on her parents.
    • “Finally, the researchers came up with Therabot, an A.I. chatbot they believe could help address an intractable problem: There are too many people who need therapy for anxiety, depression and other mental health problems, and not nearly enough providers.
    • “Fewer than a third of Americans live in communities where there are enough mental health providers to meet the local demand. According to one study, most people with mental health disorders go untreated or receive inadequate treatment.
    • “So the team at Dartmouth College embarked on the first clinical trial of a generative A.I. therapist. The results, published in the New England Journal of Medicine-AI, were encouraging.
    • “Chatting with Therabot, the team’s A.I. therapist, for eight weeks meaningfully reduced psychological symptoms among users with depression, anxiety or an eating disorder.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb on Monday said its drug Camzyos failed a Phase 3 trial in people with a progressive heart condition, closing off an opportunity to expand use of a medicine it sees as a future blockbuster.
    • “According to Bristol Myers, Camzyos missed the dual main goals of a study focused on the non-obstructive form of “HCM,” or hypertrophic cardiomyopathy. It failed to meaningfully improve peak oxygen consumption as well as scores on an assessment of heart health. The company didn’t provide study details, but said more information will be shared “with the scientific community in the future.”
    • “Camzyos was acquired through the $13 billion buyout of MyoKardia in 2020 and two years later became the first drug cleared for use in the “obstructive” and more common form of the disease. Biotechnology companies Cytokinetics and Edgewise Therapeutics are developing similar medicines that are both in the advanced stages of clinical testing. Cytokinetics’ drug, aficamten, could be approved in the U.S. later this year.”

Tuesday Report

David Ermer–AHRQ, CDC, Congress, FDA, Generative AI, Medical / Rx research, Mental health care, SCOTUS, U.S. Healthcare–

From Washington, DC

  • NBC News reports,
    • “Speaker Mike Johnson, R-La., is facing a growing rebellion from conservative hard-liners in the House as Republicans seek to take up a budget blueprint that was recently adopted by the Senate to pass President Donald Trump’s agenda.
    • “House GOP leaders are eyeing a vote this week on the measure, which would unlock the path for committees to craft a massive bill to cut taxes, boost immigration enforcement and defense spending and lift the debt limit without Democratic votes.
    • “But a slew of House conservatives have blasted the Senate’s version for requiring just $4 billion in spending cuts. The House’s version, by contrast, called for $1.5 trillion to $2 trillion in spending cuts while largely steering clear of specifics.”
  • CBS News informs us,
    • “The Centers for Disease Control and Prevention has begun redeploying staff to respond to the deadly outbreak of measles in Texas, a spokesperson said Monday, a week after steep layoffs at the agency impacted its response to the spread of the virus. 
    • “A team of three deployed yesterday to meet with county and state officials to assess the immediate needs to respond to this outbreak. The team is meeting with officials again today,” CDC spokesperson Jason McDonald said in an email. 
    • “Health and Human Services Secretary Robert F. Kennedy Jr. first said Sunday that the CDC would be redeploying to Texas at its governor’s request, after another unvaccinated child died in the measles outbreak. An 8-year-old girl was the second fatality there this year.
    • “Once the assessment is complete, more CDC staff will be sent to Texas per Sec. Kennedy’s order and the governor’s request. The first teams deployed to Texas arrived on March and returned to CDC on April 1,” McDonald said.”
  • Per MedPage Today,
    • The U.S. Preventive Services Task Force (USPSTF) still recommends primary care behavioral counseling for breastfeeding, mostly in line with its 2016 guidelines.
    • In the updated recommendation statement published in JAMA, USPSTF wrote that “providing interventions or referrals, during pregnancy and after birth, to support breastfeeding” received a B grade, indicating moderate certainty these interventions will have moderate net benefit.

From the judicial front,

  • The Wall Street Journal tells us,
    • “The Supreme Court lifted a lower-court order that directed the Trump administration to reinstate about 16,000 federal employees it fired, handing the White House the third victory in a row as it seeks the justices’ emergency action to stop district judges from slowing its policies. 
    • “The justices on Tuesday said that environmental groups and other nonprofit organizations who say they were harmed by the reduction in public services caused by the layoffs didn’t have legal standing to bring suit. 
    • “The brief order was unsigned, as is typical when the court acts on emergency requests. Two liberal justices, Sonia Sotomayor and Ketanji Brown Jackson, said they voted to deny the Trump administration’s request.” * * *
    • “The Supreme Court on Tuesday agreed with the Trump administration that the nonprofits lacked legal standing to bring the case. The court added, though, that the order didn’t address other plaintiffs in the suit, including several labor unions and the state of Washington. Alsup’s injunction wasn’t based on their claims, although those parties may face other questions regarding their standing to bring suit.
    • “Tuesday’s order doesn’t resolve broader legal disputes over the administration’s mass layoffs of federal employees.”
  • Bloomberg Law relates,
    • “A string of lawsuits targeting the use of artificial intelligence and algorithms in claims denials is raising risks for private health insurers and employers, even as the litigation encounters early obstacles.
    • “A California federal judge’s recent decision to partially allow a case to proceed over Cigna Corp.’s alleged use of algorithms to improperly deny benefits signals that automation tools come with legal hazards.” * * *
    • “To the extent that these tools are being used to block or deny coverage across the board for medically necessary services and to a large number of beneficiaries—if that is the case and that’s how these have been used, that could expose insurers to significant risk,” said David Greenberg, partner at ArentFox Schiff LLP.
    • “Courts have allowed several lawsuits to proceed, but plaintiffs still face significant challenges in making their cases. In some instances, the insurance companies denied that the plaintiffs’ medical claims were even handled by an algorithm. Proving otherwise can be difficult.”

From the public health and medical research front,

  • The American Hospital Association News points out,
    • The Centers for Disease Control and Prevention April 8 sent an alert to health care providers on measles prevention and treatment. The agency said that risk remains low for most individuals across the U.S. and that the measles, mumps and rubella vaccine is the best way to protect against the disease. 
  • and
    • “The incidence of invasive group A strep infections increased from 3.6 to 8.2 cases per 100,000 people from 2013 to 2022, according to a study authored by the Centers for Disease Control and Prevention published April 7 by JAMA. The authors concluded that accelerated efforts to prevent and control these infections are needed, especially among groups at highest risk of infection, which includes individuals 65 years or older, American Indian or Alaska Native persons, residents of long-term care facilities, people experiencing homelessness, and people who inject drugs.” 
  • Per Medscape,
    • “Around 38 million people in the United States — or slightly over 11% of the population — have diabetes, according to the National Diabetes Statistics Report. Experts only expect that number to increase, and research suggests that the burden will be especially significant in low to low-middle socioeconomic areas.
    • “Consider the Mississippi Delta, a swath of fertile land in the floodplain of the Mississippi River. It has a rich and diverse cultural heritage, with a minority-majority population, along with significant economic challenges and a persistently high poverty rate. The region also has one of the highest diabetes rates in the country, which has put the healthcare community on alert.
    • “We are more intensely screening almost everybody,” said Brent Smith, MD, a family physician in Greenville, Mississippi, and a member of the board of directors of the American Academy of Family Physicians.”
  • AP reports,
    • “Health care systems can reduce suicides through patient screening, safety planning and mental health counseling, a new study suggests, an important finding as the U.S. confronts it 11th leading cause of death.
    • “The “Zero Suicide Model” was developed in 2001 at Detroit-based Henry Ford Health, where the focus on people considering suicide included collaborating with patients to reduce their access to lethal means such as firearms and then following up with treatment.
    • “The approach made a difference, and for all of 2009, the health system saw no suicides among patients. The researchers then studied what happened when a different health system, Kaiser Permanente, adopted the program in four locations from 2012 through 2019.
    • “Suicides and suicide attempts fell in three of the locations, while the fourth maintained a low rate of suicides and attempts. Suicide attempts were tracked in electronic health records and insurance claims data. Suicides were measured using government death records.”‘
  • The Washington Post notes,
    • “Those who exercised the most had a 26 percent lower cancer risk than those who exercised the least in an analysis of biomedical data, according to research published in the British Journal of Sports Medicine.
    • “The article drew upon data from UK Biobank, a longitudinal study that enrolled 500,000 adults in Britain between 2006 and 2010. After enrolling, more than 106,000 adults were invited to participate in the sub-study on physical activity. The final sample, stratified into five groups, or quintiles, of physical activity levels, included about 85,000 participants with a median age of 63 years.” * * *
    • “The research identified an inverse relationship between overall daily physical activity and cancer risk, indicating that even modest increases in activity levels were sufficient to significantly reduce the risk of the 13 cancers. Individuals in the second-highest quintile of physical activity had a 16 percent lower risk compared with those in the lowest quintile. Higher levels of activity had a more protective effect.”
  • Per MedTech Dive,
    • “Johnson & Johnson said Monday it has enrolled the first patient in a pivotal study of a device for clearing “difficult-to-cross” coronary arteries.
    • “Like other products made by J&J’s Shockwave Medical, the Javelin intravascular lithotripsy catheter uses sound pressure waves to break up calcium deposits that are blocking blood flow. 
    • “The device is differentiated from other Shockwave products, and rival catheters from Abbott and Boston Scientific, because it emits waves from its tip. Other devices send waves from a balloon catheter that must cross the blocked part of the artery to be effective.” * * *

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “Hospital average operating margins dropped from 3.4% in January to 2.5% in February, but are still above 2024 averages, according to Kaufman Hall’s “National Hospital Flash Report.”
    • “Kaufman Hall, a Vizient company, gathered financial performance data from 1,300 hospitals. The average operating margin dropped 11% month over month but grew 5% year over year. The average operating EBITDA margin decreased 7% month over month but grew 1% year over year.
    • “Net operating revenue per calendar day increased 8% year over year, driven by an 11% jump in inpatient revenue. Outpatient revenue grew just 8% compared to February 2024.
    • “Expenses were also on the rise, with total expenses also up 8% year over year driven by a 10% growth in supply expenses per calendar day. Drug expenses and non-labor expenses both jumped 9% while labor expenses grew 6% year over year. Purchased services expenses also increased 13% from February 2024.
    • “Patient volume held steady, as discharges per calendar day were up 6% year over year in February. Observation days dropped 9% and the average length of stay was flat compared to the same period last year. Emergency department visits increased 4%.”
  • Modern Healthcare adds,
    • “Health systems announced five hospital merger and acquisition proposals in the first three months of the year, the lowest quarterly amount in more than a decade.
    • “Providers were reluctant to wade into hospital transactions amid the uncertainty surrounding tariffs, federal funding concerns, state and federal regulatory changes and economic volatility, according to a new report from consultancy Kaufman Hall. Four of the five proposed hospital deals involved financially distressed facilities, the report found.”
  • Specifically, Fierce Healthcare reports,
    • “Northwell Health and Nuvance Health’s 28-hospital merger has cleared its final regulatory hurdle and is expected to close within the next 30 days.
    • “Tuesday, Connecticut’s Office of Health Strategy announced it had reached an agreement with the two health systems after just over two months of negotiations over their Certificate of Need application. The pair’s merger, announced 14 months ago, had received a similar all-clear from New York’s Public Health and Health Planning Council last September as well as sign-offs from each state’s attorneys general during the summer.
    • “Alongside price constraints tied in part to state and regional cost growth benchmark, Northwell—the acquirer—will invest at least $1 billion into Nuvance’s Connecticut and New York hospitals and refrain from any real estate sale leasebacks over a five-year period.”
  • Fierce Healthcare also lets us know,
    • “Rural hospital leaders are questioning whether they can continue to afford to do business with Medicare Advantage (MA) companies, and some say the only way to maintain services and protect patients is to end their contracts with the private insurers.
    • “MA plans pay hospitals lower rates than traditional Medicare, said Jason Merkley, CEO of the Brookings Health System in South Dakota. Merkley worried the losses would spark staff layoffs and cuts to patient services. So, last year, Brookings Health dropped all four contracts it had with major MA companies.
    • “I’ve had lots of discussions with CEOs and executive teams across the country in regard to that,” said Merkley, whose health system operates a hospital and clinics in the small city of Brookings and surrounding rural areas.
    • “Merkley and other rural hospital operators in recent years have enumerated a long list of concerns about the publicly funded, privately run health plans. In addition to the reimbursement issue, their complaints include payment delays and a resistance to authorizing patient care.
    • “But rural hospitals abandoning their MA contracts can leave local patients without nearby in-network providers or force them to scramble to switch coverage.”
  • Per Healthcare Dive,
    • “CVS Health named a new CFO Tuesday as the healthcare giant continues to shake up its leadership team. 
    • “Brian Newman, most recently CFO of shipping and logistics firm UPS, will start at CVS on April 21. Tom Cowhey, who took on the permanent CFO position at CVS early last year, will become a strategic advisor to CEO David Joyner, effective May 12. 
    • “In addition to the leadership change, CVS said it expects financial results for 2025 to meet or exceed its previously issued guidance. In February, the company reported expected adjusted earnings for the year between $5.75 and $6 a share.” 
  • Per Beckers Hospital Review,
    • “Walgreens Boots Alliance reported a $5.6 billion operating loss in its fiscal second quarter, an improvement from the $13.2 billion loss in the same period last year as the troubled retailer continues to prepare for a private equity buyout. 
    • “Operating losses included a $3 billion impairment charge tied to its Village MD business, according to an April 8 company news release. 
    • “Despite ongoing challenges, Walgreens reported better than expected results in sales, with sales rising 4% to $38.59 billion. In addition, pharmacy sales rose 12% while retail sales fell by 3%. 
    • “The company announced last month that it would be acquired by Sycamore Partners in a deal valued at $10 billion. Walgreens also recently suspended its quarterly dividend part of a broader cost cutting effort.”
  • Per Fierce Pharma,
    • “While much of the recent GLP-1 saga has been written in the U.S., Novo Nordisk continues to expand its semaglutide empire across the globe and make inroads into large markets like Brazil.
    • “Now, in a bid to boost its production capacity in Latin America’s most populous country, Novo is plugging 6.4 billion Brazilian reais (roughly $1.09 billion) into an expansion of its manufacturing plant in the Brazilian city of Montes Claros.
    • “The investment, which marks one of the largest ever for pharmaceuticals in Brazil, will “significantly” bolster the facility’s capacity to crank out a variety of injectables, including GLP-1 medicines like Ozempic and Wegovy, Novo said in a Portuguese-language press release.”

From the artificial intelligence front,

  • Cardiovascular Business reports,
    • “Powerful Medical, a New York-based artificial intelligence (AI) company, has received the FDA’s breakthrough device designation for its AI model designed to detect signs of an ST-elevation myocardial infarction (STEMI) in electrocardiography results.
    • “The company’s PMcardio STEMI AI ECG model, nicknamed “Queen of Hearts,” identifies STEMI and STEMI-equivalent patterns in a patient’s ECG. It was trained by Stephen W. Smith, MD, an emergency physician at Hennepin County Medical Center and founder of Dr. Smith’s ECG Blog.
    • “For the last 20 years, life-saving treatment exists for heart attack patients, yet far too many still don’t receive the urgent care they need due to delays in diagnosis and inefficient triage,” said Robert Herman, MD, PhD, chief medical officer of Powerful Medical, said in a statement. “By equipping physicians and allied providers with an AI-powered tool for accurate and immediate STEMI detection, available around the clock, we can bridge this gap, ensure timely treatment, and improve patient outcomes, often preventing avoidable deaths.”
  • and
    • “Artificial intelligence (AI)-assisted mammography may be able to predict a woman’s risk of developing cardiovascular disease, according to new data being presented at ACC.25, the American College of Cardiology’s annual conference.
    • “Breast artery calcifications are already visible when radiologists review mammograms, but nothing typically happens with those findings. Researchers aimed to see if AI could do some of the heavy lifting and help translate those findings into an easy-to-understand cardiovascular risk score.
    • “The group trained an advanced AI model to segment calcified vessels in mammography images and produce a risk score that calculates the patient’s risk of developing heart disease. To help make the new-look algorithm as accurate as possible, they developed it using mammography images and electronic health record data from more than 56,000 patients. The patients were all treated from 2013 to 2020 within the Emory Healthcare health system, and at least five years of follow-up data were available for each of them.
    • “Advances in deep learning and AI have made it much more feasible to extract and use more information from images to inform opportunistic screening,” lead author Theo Dapamede, MD, PhD, a postdoctoral fellow at Emory University in Atlanta, said in a statement.”
  • Per Beckers Clinical Leadership,
    • “An AI tool that analyzes nurses’ notes for subtle clinical changes helped reduce patient risk of death by 35.6%, length of stay by 11.2% and sepsis risk by 7.5%, according to research published April 2 in Nature. 
    • “In a yearlong, multisite study, researchers assessed the tool across 74 clinical units in two health systems. Among 60,893 hospital encounters, about half involved the early warning system and the other half did not. 
    • “The system, dubbed COmmnuticating Narrative Concerns Entered by RNs (CONCERN), is a machine learning algorithm that uses real-time nursing surveillance notes and data patterns to detect all-cause deterioration risks. 
    • ‘Other EWSs often “rely on late and noisy physiologic indicators of deterioration” such as lab results and vital signs, according to the researchers. In contrast, this tool leverages nurses’ “subtle, yet observable, clinical changes that may not be captured in physiological data or well displayed in EHRs,” including small changes in mental status from baseline or slower recovery of arterial blood pressure after turning a patient.” 

Weekend Update

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medicare, Mental health care, Obesity, U.S. Healthcare–
Texas bluebonnets

From Washington, DC,

  • Roll Call reports,
    • “The Senate adopted a fiscal 2025 budget blueprint early Saturday mostly along party lines after a debate that began the night before, teeing up the House for a climactic final vote next week.
    • “Republicans beat back numerous amendments en route to adopting the measure on a 51-48 vote. 
    • “Rand Paul, R-Ky., voted “no” as he’s long promised due to the resolution’s allowance for raising the statutory debt limit by up to $5 trillion.
    • “Maine’s Susan Collins was the other GOP “no” vote, having earlier expressed concerns about potential Medicaid cuts later in the reconciliation process but not saying how she’ll vote. Collins is up for reelection in 2026 in a Democratic-leaning state.
    • “No Democrats voted for it.:
  • and
    • ​”Speaker Mike Johnson and his GOP leadership team on Saturday sought to tamp down a brewing revolt on the budget resolution that emerged even before the Senate adopted the plan in the wee hours and gained steam later in the morning.
    • “Johnson and the rest of the top four House Republican leaders sent a letter to the rank and file ahead of next week’s House vote on the Senate-revised budget blueprint assuring them that they will not accept watered-down spending cuts in the eventual filibuster-proof reconciliation bill the process is intended to unlock.
    • “We have and will continue to make it clear in all discussions with the Senate and the White House that —in order to secure House passage — the final reconciliation bill must include historic spending reductions while protecting essential programs,” the letter says.
    • “The leadership comments come after key figures in the conference, including House Budget Chairman Jodey C. Arrington, R-Texas; Freedom Caucus Chairman Andy Harris, R-Md., and Rep. Chip Roy, R-Texas, the Freedom Caucus policy chair, all expressed opposition to the Senate budget plan.” * * *
    • “The House GOP leadership letter Saturday * * * [laid] out a process they say will lead to a pre-negotiated settlement between the two chambers. 
    • “The reconciliation bill “must be drafted using a collaborative process that results in a single product that both chambers can pass, and President [Donald] Trump can sign into law,” the leadership wrote. “We have made it clear the House will NOT accept nor participate in an ‘us versus them’ process resulting in a take it or leave it proposition from the Senate.”
    • “The letter goes on to say that immediately after adopting the budget, House and Senate committees “will begin preparing together their respective titles of the reconciliation bill to be marked up in the next work period.”
    • ‘The process House GOP leaders laid out appears to follow what Democrats and then-President Joe Biden employed during the 117th Congress when they enacted two reconciliation bills. Both of those packages went through committee markups in the House, but not in the Senate; but senators were able to make their voices heard through amendment “vote-a-ramas” in that chamber.”
  • On April 9, 2025, at 10 am, the Senate Homeland Security and Governmental Affairs Committee will hold a “business meeting to consider the nominations of Scott Kupor, of California, to be Director of the Office of Personnel Management for a term of four years, and Eric Matthew Ueland, of Virginia, to be Deputy Director for Management, Office of Management and Budget.”
  • Federal News Network offers an interview with Kevin Moss about “the benefits and caveats to having both Medicare and FEHB. While enrolling in Medicare with FEHB coverage may seem like duplicating benefits, it can provide cost savings.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • A second child who was diagnosed with measles has died in Texas, marking another death in a growing measles outbreak that has so far sickened hundreds of people, hospitalized dozens and spread to nearby states. 
    • The school-age child was being treated for measles-related complications at UMC Health System in Lubbock, Texas, said the health system’s spokesman, Aaron Davis. The child, who died Thursday, wasn’t vaccinated, didn’t have any known underlying health conditions and died of “measles pulmonary failure,” according to the Texas Department of State Health Services.
    • “This unfortunate event underscores the importance of vaccination,” Davis said. * * *
    • “Health and Human Services Secretary Robert F. Kennedy Jr. traveled to Gaines County, Texas, the center of the measles outbreak, to console the two families who have lost children, he said in a post on X.” 
  • STAT News adds,
    • “Health secretary Robert F. Kennedy Jr. said Sunday that “the most effective way to prevent the spread of measles is the MMR vaccine,” his most direct statement yet on the issue, following the death of a second child of the condition in the outbreak in West Texas.” 
  • The Washington Post informs us,
    • Brandy Ellis [, a 49-year-old insurance compliance consultant] calls herself a cyborg.
    • Two small electrodes — thin metal wires — implanted deep inside her brain lead under her skin to a battery pack in her chest. Pulsing about 130 times a second, the deep brain stimulation (DBS) device, a kind of pacemaker, energizes an area that scientists say is key in regulating moods. * * *
    • “DBS is one of several emerging, high-tech therapeutic approaches — a.k.a. electroceuticals — that proponents say are extending psychiatry’s ability to help millions of patients. Increasingly over the past 20 years, testimonials to the potential of treatments that modulate brain functioning, such as DBS, transcranial magnetic stimulation, vagus nerve stimulation and, most recently, focused ultrasound, have been fueling new hope, despite considerable expense and hardship for patients, and mixed evidence of their effectiveness.
    • “Emory University neurologist and psychiatrist Patricio Riva Posse, one of Ellis’s therapists, describes the new trends — combined with ever more sophisticated brain-scanning technologies and new optimism about psychedelic drugs such as ketamine and psilocybin — as explosive progress.”
  • Per Medscape,
    • This patient case [discussed in the article] is a prime example of how, in some instances, losing weight with glucagon-like peptide 1 (GLP-1) agonists can impact muscle mass. To combat this health risk, more clinicians are now emphasizing on fat loss vs weight loss in patients taking GLP-1s. Weight loss refers to the overall decrease in weight from the body, which can include fat, muscle, and water, whereas fat loss refers only to the reduction of fat from the body.

From the U.S. healthcare business front,

  • BioPharma Dive provides us with an “M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals. Big-ticket biotech buyouts have become scarce in recent months. U.S. policy upheaval threatens to keep it that way.”
  • Here is a link to Optum Rx’s Winter 2025 report on notable new drugs.
  • Per MedTech Dive,
    • “Eargo and Hearx have merged to create the over-the-counter hearing aid company LXE Hearing, the companies said Monday.
    • “Hearx, the maker of Lexie hearing aids, and Eargo competed for the OTC hearing aid market that the Food and Drug Administration created through the publication of a final rule in 2022. 
    • “Patient Square Capital, which took Eargo private in 2024, has invested $100 million in the combined company. LXE said the investment reflects confidence in the direct-to-patient hearing market.”
  • HR Dive relates,
    • “The U.S. Equal Employment Opportunity Commission has reached a settlement in two pregnancy discrimination cases and filed a new lawsuit on a third, the agency announced Thursday in a series of media releases.
    • “In the first settlement, an assisted living facility paid $20,000 to resolve allegations that it refused to schedule and then fired a temporary worker upon learning she was pregnant. In the second, a plant nursery paid $40,000 to resolve allegations it did not allow a worker to return after maternity leave. EEOC’s newly filed lawsuit alleged an employer refused to allow a worker with a high-risk pregnancy to work remotely to limit her exposure to COVID-19.  
    • “The actions highlight the agency’s continued interest in enforcing the relatively new Pregnant Workers Fairness Act. However, Acting Chair Andrea Lucas has expressed her opposition to aspects of the agency’s final rule, which was passed in April 2024.”

From the artificial intelligence front,

  • The Washington Post reports,
    • “In 2017, Ezekiel Emanuel, a well-known oncologist and health policy commentator, said radiologists would soon be out of work thanks to machine learning.
    • “That hasn’t happened, but although artificial intelligence isn’t replacing radiologists, it has significantly changed their field.
    • “More than three-quarters of the AI software cleared by the Food and Drug Administration for medical use is designed to support radiology practice, says Curtis Langlotz, a radiology professor at Stanford University and president of the Radiological Society of North America’s board of directors.
    • “Radiology is leading the way in the development and implementation of AI in clinical practice,” he adds. But AI isn’t reducing the need for human input.
    • “AI is not a better kind of intelligence, it’s just a different kind of intelligence,” Langlotz says. “A human plus a machine is better than either one alone. I would say that has been true since I began studying AI in the 1980s, and it continues to be true today.”

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.” 

Thursday Report

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

From Washington, DC

  • Roll Call lets us know,
    • “Senate Majority Leader John Thune told GOP senators Wednesday that a compromise budget resolution could hit the floor for a “vote-a-rama” as soon as next week, which would allow the House to adopt it the following week before the two-week April recess.
    • “This accelerated time frame, if both chambers can adhere to it, would let Republicans hit the ground running after the recess to write the “big, beautiful” budget reconciliation bill that President Donald Trump wants.
    • “Speaker Mike Johnson, R-La., has set an informal deadline of Memorial Day to send the measure to Trump, including a massive tax cut package, more money for defense and border security, domestic energy incentives, a debt limit increase and trims to mandatory spending.
    • “As recently as Tuesday, Thune, R-S.D., had been telling colleagues that Senate consideration could slip to the week of April 7, which likely wouldn’t give the House time to act before the recess.
    • “But discussions made a big leap on Wednesday with a new strategy: provide a different, lower set of spending cut targets for Senate committees than their House counterparts. Under this scenario, the final budget resolution adopted by both chambers would “instruct” House and Senate committees differently.” * * *
    • “Both sets of instructions would be in the final budget resolution, and then the two chambers could hammer out differences later on what the actual reconciliation details look like.
    • “What needs to ultimately be reconciled is the final bill. The resolution’s looking different in two chambers, I don’t think anybody’s getting worked up about that,” Sen. Eric Schmitt, R-Mo., said Wednesday. “But eventually everybody does kind of need to unlock the process, which is what the resolution is for.”
    • “The working theory is that eventually what matters for “Byrd rule” enforcement in the Senate is whether that chamber’s reconciliation instructions are adhered to.”
  • and
    • “President Donald Trump on Thursday announced he would withdraw the nomination of New York Rep. Elise Stefanik to be U.S. ambassador to the United Nations, citing a need for Republicans to keep her seat amid narrow margins in the House. 
    • “With a very tight Majority, I don’t want to take a chance on anyone else running for Elise’s seat,” Trump posted on his Truth Social platform. “The people love Elise and, with her, we have nothing to worry about come Election Day. There are others that can do a good job at the United Nations.”
  • The American Hospital Association News tells us,
    • “The AHA March 27 voiced opposition to the Physician Led and Rural Access to Quality Care Act (H.R. 2191), a bill that would lift the ban on the establishment of physician-owned hospitals in certain rural areas and permit the unfettered expansion of POHs nationwide, regardless of location. In place since 2010, current law includes an exceptions process that allows existing POHs to expand if they accept Medicaid patients and are located in areas where beds are needed. 
    • “By performing the highest-paying procedures for the best-insured patients, physician-owners inflate health care costs and drain essential resources from community hospitals, which depend on a balance of services and patients to provide indispensable treatment, such as behavioral health and trauma care,” AHA wrote in comments to Rep. Morgan Griffith, R-Va., the bill’s author. “By increasing the presence of these self-referral arrangements, H.R. 2191 would only further destabilize community care.” 
  • Per a news release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced a dramatic restructuring in accordance with President Trump’s Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.”
    • “The restructuring will address this and serve multiple goals without impacting critical services. First, it will save taxpayers $1.8 billion per year through a reduction in workforce of about 10,000 full-time employees who are part of this most recent transformation. When combined with HHS’ other efforts, including early retirement and Fork in the Road, the restructuring results in a total downsizing from 82,000 to 62,000 full-time employees.
    • “Secondly, it will streamline the functions of the Department. Currently, the 28 divisions of the HHS contain many redundant units. The restructuring plan will consolidate them into 15 new divisions, including a new Administration for a Healthy America, or AHA, and will centralize core functions such as Human Resources, Information Technology, Procurement, External Affairs, and Policy. Regional offices will be reduced from 10 to 5.
    • “Third, the overhaul will implement the new HHS priority of ending America’s epidemic of chronic illness by focusing on safe, wholesome food, clean water, and the elimination of environmental toxins. These priorities will be reflected in the reorganization of HHS.
    • “Finally, the restructuring will improve Americans’ experience with HHS by making the agency more responsive and efficient, while ensuring that Medicare, Medicaid, and other essential health services remain intact.” * * *
    • For more detailed information, please visit our fact sheet.
  • The HHS reorganization is worth a shot in view of the thirty yearlong federal budget outlook from the Congressional Budget Office.
  • Tammy Flanagan, writing in Govexec, offers federal retirement advice in these uncertain times.

From the public health and medical research front,

  • Medpage Today informs us,
  • and
    • “A flea-borne disease that was once largely eradicated from the U.S. may be making a resurgence, CDC researchers said during a clinician-focused call on Thursday.
    • “Murine typhus became so rare after public health efforts against it in the 1940s that it eventually stopped being a nationally notifiable disease.
    • “But now, cases are on the rise in two states that actively monitor the disease — Texas and California — and the illness may be going undiagnosed, experts said.”
  • Per a National Cancer Institute news release,
    • “Scientists have long been exploring ways to kill cancer cells by starving them of the nutrients they need to survive. A new study suggests that genetically modified fat cells could help researchers realize this goal.
    • “In the study, researchers genetically engineered white fat cells—the most common type of fat in the body—to aggressively consume nutrients such as glucose and fatty acids. When the engineered fat cells were implanted near tumors in mice, the tumors grew more slowly than tumors in mice without the engineered cells.
    • “The approach slowed the growth of cancer in mice even when the engineered fat cells were implanted far from a tumor, the researchers reported in Nature Biotechnology on February 4. 
    •  “We believe the engineered cells are outcompeting tumors for essential nutrients, suppressing the proliferation of cancer cells,” said study leader Nadav Ahituv, Ph.D., director of the University of California, San Francisco (UCSF) Institute for Human Genetics. “The findings suggest that engineered fat cells could be a new form of cellular therapy.”
  • Per Healio,
    • “Survivors [of metastatic breast cancer] who participated in [telephone-delivered] acceptance and commitment therapy reported less fatigue interference with functioning.
    • “Researchers are studying the approach for people with advanced gastrointestinal cancer.”

From the U.S. healthcare business front,

  • Fierce Healthcare tells us,
    • “Nonprofit hospitals’ 2024 financial performances are beating the prior year’s tough numbers, though even the stronger organizations remain “well below pre-pandemic levels,” Fitch Ratings said.
    • “In a Thursday brief describing the financial profiles of its rated nonprofit hospitals, the agency attributed the year-to-year improvements to stronger revenues and volumes as well as slightly mitigated, but still pressured, labor spending.
    • “Fitch said the median operating margin among hospitals with early fiscal year ends (often June 30) was 1.2%, a flip from the prior year’s -0.5%. The agency said it expects the calendar year 2024 median margin for the remainder of its rated hospitals “will at least be in line” with the former group.”
    • “Persistent” labor pressures continue to push base salary and wage expenses upward by a median 6.9% among the rated hospitals, which Fitch said “would have been even higher without the sector’s ongoing efforts to recruit and retain talent, streamline operations and optimize supply chains.”
  • Beckers Hospital Review notes,
    • “Doylestown (Pa.) Health will officially join the University of Pennsylvania Health System on April 1, marking a significant expansion of Penn Medicine’s reach into Philadelphia’s northern suburbs. 
    • “The transaction follows regulatory reviews and approvals from the Pennsylvania Attorney General’s Office and the Federal Trade Commission.
    • “Under the new structure, Doylestown Health and its affiliates will be rebranded as Penn Medicine Doylestown Health. The integration combines one of the country’s leading academic health systems with a regional health system.” 
  • and
    • “Four blockbuster GLP-1 medications are expected to be among the 10 best-selling drugs in 2026, accounting for $66.8 billion in global sales, according to market research company Statista
    • “Statista predicts Ozempic will yield $22.3 billion in 2026, followed by Mounjaro with $19.8 billion, Wegovy with $13.4 billion and Zepbound with $11.3 billion.” 
  • Modern Healthcare reports,
    • “When Florida Blue wanted its call center employees to demonstrate greater emotional intelligence when dealing with customers, the nonprofit health insurance company enlisted a tutor incapable of emotion.
    • “A generative artificial intelligence, or genAI, chatbot instructs 30 Florida Blue customer service representatives on how to behave like human beings when interacting with other human beings. The chatbot guides workers on human behaviors, such as when to slow their speech, when to hasten a call to its conclusion and what to recommend to policyholders. The company plans to expand this pilot program to its entire 1,600-person call center team this year.
    • “A lot of the time, people carry emotion into calls with health insurers. When you’re upset, it just comes out. One of the prompts is to remind the advocate, ‘Hey, this member appears to be stressed. Make sure you’re pausing and listening to them,’” said Anne Hoverson, vice president of digital transformation at Florida Blue, a subsidiary of Guidewell.
    • “Insurance companies already used genAI for processing claims, predicting clinical needs and performing administrative functions, but this latest trend is different, said Josh Streets, a senior consultant at the International Customer Management Institute, which advises business on call centers.”
  • and
    • “GE HealthCare announced Thursday the commercial launch of Flyrcado, its PET imaging agent that assesses blood flow to the heart muscle, in select U.S. markets.
    • “The Centers for Medicare and Medicaid Services granted Flyrcado pass-through status starting April 1, allowing separate payments for the imaging agent and the PET/CT scan in hospital outpatient settings.
    • “In late September, the company announced that Flyrcado received Food and Drug Administration approval to detect coronary artery disease. It provides more accurate diagnostics than SPECT imaging, the current standard in cardiac nuclear medicine imaging, according to GE HealthCare.
    • “Since Flyrcado has a half-life of 109 minutes, which is significantly longer than other similar PET imaging agents, healthcare facilities don’t need to produce it on-site. Instead, it can be manufactured at off-site pharmacies and delivered as needed.”

Midweek Update

David Ermer–CMS, Congress, FDA, Generative AI, Medical / Rx research, NIH, SCOTUS, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • It turns out that at yesterday’s markup meeting, the House Oversight and Government Reform Committee did clear HR 2193, the FEHB Protection Act of 2025, for floor consideration, along with the other bills considered during the markup.
  • The Senate confirmed James Bishop to be Deputy Director of the Office of Management and Budget by a 53-43 vote.
  • CMS today released a “Revised Final 2026 Actuarial Value (AV) Calculator Methodology.”
    • “The only changes that are being made to the Final 2026 AV Calculator as part of this Revised Final 2026 AV Calculator are the following:
      • “The de minimis range for bronze, silver, gold and platinum plans was expanded to +2
      • percentage points to -4 percentage points;
      • “The de minimis range for expanded bronze plans was expanded to +5 percentage points
      • to -4 percentage points;
      • “The de minimis range for income-based silver CSR plans was expanded to +1 percentage
      • points to -1 percentage points;
      • “The MOOP limit was updated to $10,600; and
      • “The AV Calculator version number was updated, and the AV Calculator label was
      • updated to “Revised Final 2026 AV Calculator”.
    • “These changes do not affect the AV calculation methodology. All AV calculations are the same
    • in both the Final 2026 AV Calculator and the Revised Final 2026 AV Calculator.”
  • The Congressional Research Service has summarized the federal requirements on private health insurance plans.
  • Per the American Hospital Association (“AHA”) News,
    • “The FBI March 26 advised that, after extensive investigation and intelligence review, they have not identified any specific credible threat targeted against hospitals in any U.S. city. The FBI advised if they receive credible threat information, they will immediately advise any identified potential targets and, if appropriate, alert the broader health care sector through the AHA, the Health-ISAC (Information Sharing and Analysis Center) and other appropriate channels. 
    • “On March 18, the AHA and Health-ISAC received multiple reports from the field regarding a public social media post alleging active planning of a coordinated, multi-city terrorist attack targeting hospitals in the coming weeks. 
    • “Out of an abundance of caution, the AHA and Health-ISAC notified the field of the potential threat, indicating that no further information was available to either corroborate the threat or dismiss it as not credible. The AHA and Health-ISAC today distributed an updated bulletin to members with the latest update from the FBI.” 

From the judicial front,

  • Bloomberg Law informs us,
    • “The US Supreme Court suggested [during an oral argument today] it’s likely to uphold a federal program that uses more than $8 billion in fees imposed on phone bills to subsidize the cost of telecom services for poor people, rural residents, schools and libraries.
    • “Hearing arguments in Washington on the decades-old Universal Service Fund, some conservative justices voiced concern that Congress had unconstitutionally handed off its taxing power to the Federal Communications Commission without imposing sufficient limits [also known as the non-delegation doctrine].”

In Food and Drug Administration news,

  • BioPharma Dive relates,
    • “The Food and Drug Administration on Wednesday approved the first treatment for the insatiable hunger associated with the rare disease Prader-Willi syndrome, a long-awaited decision that follows an unorthodox pitch from the drug’s developer.
    • “The agency on cleared Vykat XR, from biotechnology company Soleno Therapeutics, for this hyperphagia that’s caused by Prader-Willi. Treatment has specifically been approved for adults and children at least four years of age. Soleno hasn’t yet disclosed the drug’s list price. 
    • “The approval is a milestone for research into a disease that’s proven difficult to target. Prader-Willi affects an estimated 10,000 to 20,000 people in the U.S. and causes multiple cognitive and behavioral symptoms.”
  • Per a National Cancer Institute (NCI) news release,
    • “The Food and Drug Administration (FDA) has given an accelerated approval to zenocutuzumab (Bizengri), making it the first drug that targets tumors with a very rare genetic alteration called an NRG1 fusion. Under the approval, zenocutuzumab can be used to treat people with pancreatic or non-small cell lung cancer (NSCLC) whose tumors have an NRG1 fusion and whose disease has gotten worse despite standard treatments.
    • “The approval was based on the results of a clinical trial in which one-third of patients treated with zenocutuzumab had sustained tumor shrinkage of at least 30% that lasted a median of 11 months. Most of the patients in the study had either NSCLC or pancreatic cancer.
    • “This is a patient population that has a very high unmet need,” said the study’s lead investigator, Alison Schram, M.D., of the Memorial Sloan Kettering Cancer Center. “This approval gives these patients, who have very few effective therapeutic options, a new treatment option.”
    • “Because it’s an accelerated approval, Partner Therapeutics, which licensed zenocutuzumab from Merus, must conduct additional studies to confirm that the drug helps patients clinically, which can include helping them live longer than with other treatments.’

From the public health and medical research front,

  • The New York Times reports,
    • Measles cases in Kansas more than doubled in the last week, bringing the tally to 20, while another outbreak in Ohio has sickened 10 people, local public health officials reported on Wednesday.
    • There have been several large outbreaks in the United States this year, including one in West Texas that has spread to more than 320 people and hospitalized 40. Health officials have worried that the Texas outbreak may be seeding others.
    • More than 40 measles cases have been reported in New Mexico, and seven have been identified in Oklahoma. In both states, health officials said the infections were connected to the Texas outbreak.
    • In Kansas, the virus has mainly infected unvaccinated children in the southwest corner of the state. Genetic sequencing has suggested a link to the Texas and New Mexico outbreaks, state health officials told The New York Times on Wednesday.
  • Per the AHA News,
    • “A study published March 26 by the National Institutes of Health and the University of Oxford found that individuals who engaged in light and moderate-to-vigorous daily physical activity had a lower cancer risk than those with more a sedentary lifestyle. The study found that higher daily step counts, but not pace, was also associated with a lower cancer risk. In comparison to cancer risk for individuals taking 5,000 steps per day, risk was 11% lower for those taking 7,000 steps per day and 16% lower for those taking 9,000 steps per day. Risk reduction plateaued beyond 9,000 steps.”
  • This week’s Cancer Information Highlights from the NCI discuss “Quit Smoking | Metastatic Prostate Cancer | Kidney Cancer.”
  • The National Institute of Standards and Technology informs us,
    • “A rare but painful disorder can make it difficult for people to swallow food. The symptoms include weight loss and chest pain after eating. Scientists are working to better understand this condition, known as corkscrew esophagus, in hopes of finding more treatment or prevention options.
    • “We are working to contribute to that effort with an approach you may not associate with medical research. It involves math, physics and computer modeling.”
  • Medscape points out,
    • “In a recent final analysis of a phase 3 trial, the bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine [which are FDA approved] maintained high efficacy and a favorable safety profile against RSV-associated lower respiratory tract illness (RSV-LRTI) over two seasons in people aged ≥ 60 years.”
  • STAT News tells us, “Study suggests mRNA vaccine could make humans resistant to ticks that transmit Lyme bacteria. New tool shows how the human immune system responds to components of ‘tick cement.’”
    • “Ticks, once latched onto a fleshy target with their barbed, needle-like mouths, are ready for almost anything. They glue themselves to the skin using a complex, cement-like substance. And then, like a “little pharmacological company,” they dole out proteins to keep the blood flowing, make it relatively painless, and hamper any immune response that might reveal their parasitic presence, Yale University researcher Erol Fikrig says.
    • “It’s in those days of quiet blood-thirst that ticks pass along bacteria that causes conditions like Lyme disease, a growing problem driven in the U.S. by black-legged ticks (or Ixodes scapularis). Researchers have been trying for decades to understand just how the tiny tick is able to evade the human body’s defenses and pass along pathogens. 
    • “A new study by Fikrig and other researchers, published Wednesday in Science Translational Medicine, uses a powerful monitoring system to reveal how the human immune system is responsive to a litany of tick triggers — some of which might be leveraged to create a protective mRNA vaccine.” 
  • Per Fierce Pharma,
    • “Johnson & Johnson has produced the most convincing data to date that its combination of Rybrevant and Lazcluze could replace AstraZeneca’s Tagrisso as the new standard of care in first-line EGFR-mutated non-small cell lung cancer—proof it could extend patients’ lives.
    • “The Rybrevant-Lazcluze combo significantly reduced the risk of death by 25% versus Tagrisso in patients with newly diagnosed advanced EGFR-mutated NSCLC, according to data from the phase 3 Mariposa trial presented at the European Lung Cancer Congress (ELCC) 2025.
    • “While the median overall survival time was not yet reached for the combo, investigators expect that the J&J regimen could offer at least an extra year of life versus Tagrisso, on which patients have logged a median 36.7 months of survival.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Fewer physicians are considering leaving the profession in 2025 than in 2024, according to a new survey from the Harris Poll and electronic health record provider Athenahealth.
    • “Part of physicians’ improved job satisfaction was driven by increased adoption of artificial intelligence, the researchers said. Fewer physicians reported the technology was over-hyped this year, and they saw the most promise in transcription services and capabilities.
    • “Still, physicians shared concerns about the fate of the industry long-term and only 3 in 10 physicians were optimistic about the direction of U.S. healthcare generally. Respondents were most concerned about interoperability challenges, their organization’s financial health and meeting regulatory requirements.”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec (Nanoscope Therapeutics) for the treatment of advanced retinitis pigmentosa.”
      • Key Clinical Findings
        • “For adults with advanced retinitis pigementosa and severe vision loss, ICER rated the current evidence on sonpiretigene isteparvovec as promising but inconclusive (“P/I”) due to concerns about durability of benefits and unknown short-term and long-term harms.
      • Key Cost-Effectiveness Findings
        • “Sonpiretigene isteparvovec has not yet been approved by the FDA for retinitis pigmentosa, and the manufacturers have not yet announced a US price for the therapy if approved. 
        • “ICER has calculated a health benefit price benchmark (HBPB) to be between $67,400 and $101,300 for treatment in one eye.”
  • The Brown & Brown consulting firm has posted an executive summary of its 2025 Employee Health and Benefits Strategy Survey.
  • Beckers Health IT survey notes,
    • “Amazon is testing a generative AI-powered health assistant, dubbed Health AI, on its website and mobile app, CNBC reported March 25.
    • “The chatbot is designed to answer health and wellness questions, suggest common care options for various medical needs, and recommend products. Some responses are marked with a “clinically verified” badge, indicating that the information has been reviewed by U.S.-based licensed clinicians, according to Amazon.
    • “In addition to providing health guidance, Health AI directs users to Amazon’s online pharmacy and clinical services from One Medical, the primary care provider Amazon acquired for $3.9 billion in 2022.”

Thursday Report

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

Happy first day of Spring!

From Washington, DC,

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

From the public health and medical research front,

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

From the artificial intelligence front,

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

From the U.S. healthcare business front,

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

Monday Report

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

From Washington, DC,

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

From the judicial front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, Patient safety, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) threw a wrench into a Republican plan to avert a government shutdown this weekend, saying there wasn’t enough Democratic support to advance the measure funding federal agencies through Sept. 30.
    • “Republicans “do not have the votes in the Senate,” to move the resolution forward, Schumer said on the Senate floor, indicating that his party was prepared to block it. He blamed Republicans, saying they “chose a partisan path” in their bill without any input from congressional Democrats.  
    • “As an alternative, Schumer floated a shorter-term plan that would fund the government for a month. “I hope my Republican colleagues will join us to avoid a shutdown on Friday,” he said.
    • “Government funding will lapse at 12:01 a.m. Saturday if Congress doesn’t act. The GOP-led House left town after it approved Republicans’ resolution on Tuesday, effectively giving the Senate no time to revise the bill—but to simply pass it or reject it.”
  • The Hill adds,
    • Some Democrats floated the idea that an amendment vote on the 30-day CR, which would fail, could be won in exchange for the requisite number of votes to advance the GOP bill. Some Republicans could support it, according to Sen. Tim Kaine (D-Va.), but not enough that it would be adopted. 
    • “It remains unclear whether Republicans would go along with that though. Senate Majority Leader John Thune (R-S.D.) did not fully shoot down the idea. 
    • “I think there would have to be some understanding,” he told The Hill on Wednesday evening. “We’ll see. I’m not sure exactly what their demand is — if they just need a vote on that, and if in exchange for that they’ll give us the votes to fund the government.”
    • “Thune added that discussions are “going on right now” on a path forward, but he also panned the idea of a full shift to a 30-day CR in order to finish 2025 appropriations bills.”
  • The Wall Street Journal further tells us,
    • “The Centers for Medicare and Medicaid Services plans to terminate four demonstration projects at the end of 2025, closing out models affecting primary care, kidney care and healthcare payments in the state of Maryland.
    • “The agency will also make changes to other projects, including dropping a planned initiative that would offer certain generic drugs to Medicare enrollees for $2. CMS said its planned terminations would save nearly $750 million, and an agency official said the projects would affect millions of patients.”
  • Per Modern Healthcare,
    • “Johnson & Johnson MedTech said Wednesday its Monarch Quest robotic platform received clearance from the Food and Drug Administration.
    • “Robotic-assisted bronchoscopy is a minimally invasive technique that allows surgeons to reach airways and suspicious lung nodules.”

From the public health and medical research front,

  • The New York Times reports,
    • “Measles continues to spread in West Texas and New Mexico, with more than 250 people infected — many unvaccinated school-age children. Two cases in Oklahoma, for which state officials have not provided a location, have also been linked to these outbreaks. Twelve other states have reported isolated measles cases, typically linked to international travel.”
  • The American Medical Association lets us know what doctors wish patients knew about measles.
  • STAT News reminds us,
    • “The 2020s have inarguably been Covid-19’s decade. 
    • “Since the coronavirus outbreak was acknowledged as a pandemic exactly five years ago, the pandemic has killed well over 1 million Americans, derailed the global economy, and sparked political upheaval that continues today. It also yielded what many hail as the greatest scientific accomplishment in human history: the development of effective vaccines in under a year. 
    • “Yet in dominating the early 2020s, Covid-19 also distracted from what is arguably a more significant public health emergency. Even at the height of the pandemic, more young Americans died of drug overdose than Covid. And in the last year, the overall death toll from the country’s drug crisis has exceeded the Covid-19 pandemic as the deadliest health event this generation.”
  • MedPage Today notes,
    • “Using only targeted models of syphilis screening in the emergency department (ED) would miss large proportions of active syphilis cases as well as new HIV diagnoses and acute HIV cases, according to new research.
    • “Only screening patients for syphilis who came to the ED for gonorrhea and chlamydia testing would have missed 76.4% of positive syphilis screens as well as 68.7% of new HIV diagnoses, reported Kimberly Stanford, MD, MPH, of the University of Chicago Medical Center.”
  • Healio informs us,
    • “An increase in depressive symptoms was observed among U.S. teenagers without, rather than with, behavioral risk factors, underscoring the need for greater screening in this population, data show. 
    • “Over the last decade, national survey data has revealed a sharp rise in depressive symptoms among U.S. adolescents,” Tanner J. Bommersbach, MD, MPH, child and adolescent psychiatrist and assistant professor at the University of Wisconsin School of Medicine and Public Health, told Healio regarding the research presented in The Lancet Regional Health Americas. “Yet, surprisingly little is known about what is driving this increase and which adolescents are most affected.”
  • Consumer Reports, writing in the Washington Post, explains what to do about ear pain.
  • Per a National Institutes of Health press release,
    • “The antiviral drug tecovirimat used without other antivirals did not reduce the time to clinical resolution of clade II mpox lesions or improve pain control among adults in an international clinical trial sponsored by the National Institutes of Health (NIH). The trial enrollment was stopped in late 2024 when an interim analysis showed that tecovirimat monotherapy was ineffective in the study population. Detailed results were presented at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.
    • “This study brought us a step forward in better understanding mpox disease and potential treatment strategies,” said Jeanne Marrazzo, M.D., M.P.H., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which sponsored and funded the trial. “We are grateful to the study team and participants for their contributions to groundbreaking research on a disease that we still do not know enough about.”
  • The National Cancer Institute’s Cancer Information Highlights cover the following topics this week: “AI and Immunotherapy | Breast Reconstruction | Multiple Myeloma Research.”
  • Food Safety Magazine alerts us,
    • “The U.S. Centers for Disease Control and Prevention (CDC) has released a summary analyzing the causes of foodborne illness outbreaks that occurred between 2014 and 2022. Data included in the analysis was drawn from the Foodborne Disease Outbreak Surveillance System (FDOSS), via the National Outbreak Reporting System (NORS).
    • “According to CDC, approximately 800 foodborne illness outbreaks occur in the U.S. each year, causing an estimated 15,000 illnesses, 800 hospitalizations, and 20 deaths, annually.
    • “An overall trend revealed in the FDOSS data for 2014–2022 included that many foodborne illness outbreaks occur because of contamination of food by an animal or environmental source before arriving at the point of final preparation. Additionally, most viral outbreaks are caused by contamination from ill food workers. The data showed that common contributing factors to bacterial outbreaks are 1) allowing foods to remain out of temperature control for a prolonged period, and 2) inadequate time and temperature control during cooking.”
  • The American Hospital Association News relates,
    • “The AHA and Press Ganey March 12 released a new report showing hospital and health system patients reporting improvements in overall care experience and perception of safety alongside gains in key safety outcomes. It also shows that the health care workforce has had a rebound in their reported experience, resilience and perceptions of safety culture.
    • “The insights report, “Improvement in Safety Culture Linked to Better Patient and Staff Outcomes,” highlights how hospitals that foster a strong culture of safety also report a better experience for patients and the health care workforce.
    • “Key report findings include: 
      • “13 million patients surveyed after hospital stays report improvements in their overall care experience and perception of safety.
      • “Surveys of 1.7 million members of the health care workforce show a rebound in their reported experience, resilience and perceptions of safety culture, following the enormous strain of the COVID-19 pandemic.
      • “Improvements in key safety outcomes like falls and infections across more than 25,000 units in 2,430 hospitals.”
  • Per MedTech Dive,
    • “Capstan Medical says it has notched a first in the treatment of structural heart disease, employing a robot to implant two people with mitral valve replacement devices.
    • “Current treatment options for heart valve disease exclude too many patients who are not good candidates for existing procedures, said Capstan CEO Maggie Nixon, and the company hopes its approach will provide them with a new alternative.
    • “The Santa Cruz, California-based startup is developing a valve implant, catheter and robotic delivery platform to expand structural heart intervention to a broader group of people.
    • “There need to be more percutaneous, minimally invasive options to help treat valve disease,” Nixon said in an interview.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Blue Shield of California President and CEO Lois Quam is out at the company two months after taking the helm.
    • “The company declined to explain the circumstances of Quam’s immediate departure.
    • “Chief Financial Officer Mike Stuart will serve as interim president and CEO until the board names a permanent successor, the company said in a news release Tuesday. Stuart has worked at the nonprofit insurer for more than a decade, the company said.
    • “Quam joined the company as president in August after having served as CEO of Pathfinder, a nonprofit global health organization. She was named CEO in early January as part of a corporate restructuring and was touted as its first female CEO.”
  • Fierce Healthcare reports,
    • “Health technology company Innovaccer launched a new platform that seeks to make it easier for insurers to manage risk adjustment and quality improvements.
    • “On Wednesday, Innovaccer unveiled the 360-Degree Gap Closure Solution, which assist payers in improving coding accuracy and patient outcomes. The tool comes at a time when the industry is under significant scrutiny from regulators over coding practices.
    • “The platform enables better engagement across different care settings, greater automation and data governance, Innovaccer said. Health plans can deploy one-click campaigns that address care gaps in a way that reaches provider offices, pharmacies and home healthcare.”
  • Per BioPharma Dive,
    • “Roche has raised its bet on obesity, agreeing to pay Zealand Pharma $1.65 billion to license an experimental shot the Danish company put into a Phase 2b trial in December, Zealand said Wednesday.
    • “Per deal terms, Roche will pay $1.4 billion immediately and $250 million in anniversary payments to license petrelintide. With further milestone payments, Zealand could receive up to $5.3 billion. Roche and Zealand will co-commercialize the shot in the U.S. and Europe, and share in any profits and losses.
    • “The deal gives Roche access to a type of experimental drug known as an amylin analog, a class the Swiss pharmaceutical company didn’t obtain when it acquired Carmot Therapeutics 15 months ago. Roche plans on testing petrelintide with one of those drugs, for which Zealand could reimburse Roche $350 million.”
  • Per MedTech Dive,
    • “Labcorp will pay up to $225 million to acquire the oncology diagnostics businesses of BioReference Health, a subsidiary of Opko Health, to expand its portfolio of tests used in cancer care.
    • “The deal, announced Tuesday, includes $192.5 million to be paid at closing and a payment of up to $32.5 million based on performance. 
    • “The assets, including certain customer accounts, generate about $85 million to $100 million in annual revenue, according to the announcement. Labcorp expects the acquisition to be accretive to earnings in the first year after closing.”
  • Healthcare Dive relates,
    • “Hospital operator Landmark Holdings of Florida filed for Chapter 11 bankruptcy protections on March 9, becoming the latest in a growing number of embattled providers to restructure amid financial headwinds. 
    • “In first day court filings, Landmark, which owns or operates six long-term acute care hospitals across three states, said rising labor and pharmaceutical costs, as well as stagnating Medicare reimbursements, had dinged Landmark’s profitability and threatened the provider’s ability to make timely loan repayments.”
    • “Still, Landmark told the court it expects to have enough cash on hand to keep its hospitals open through the bankruptcy process.:
  • STAT News lets us know,
    • While there are no official statistics on the number of end-of-life doulas in the United States as this emerging field is still largely unregulated, Fortune reports that the National End-of-Life Doula Alliance (NEDA) has significantly grown its membership, especially after the pandemic. In 2024, NEDA had over 1,500 registered members, compared to about 250 in 2019. 
    • “The term “end-of-life-doula” was first formally used in the early aughts. In 2001, the Jewish Board of Family and Children’s Services launched the “Doula to Accompany and Comfort Program,” a pilot program that trained volunteers to aid and support people who would otherwise die alone. 
    • “Sometimes known as “death doulas,” [these] professionals * * *help people navigate what can be a confusing and overwhelming time.”