Weekend update

OPM

Weekend update

David Ermer–CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, Obesity, OPM, U.S. Healthcare–

Happy Easter!

From Washington, DC,

  • Congress remains on a State/District work break this week. Both Houses of Congress return to Capitol Hill on April 13.
  • Govexec reports,
    • “President Trump’s fiscal 2027 budget proposal, released Friday morning, would freeze federal civilian employees’ pay in 2027, all while granting a sizeable raise for members of the armed services.
    • “An Office of Management and Budget spokesperson told Government Executive that under Trump’s budget, civilian workers would receive no pay increase next January. But under the plan, members of the military would receive between a 5% and 7% pay increase, with the highest raises going to the lowest ranked personnel.”
  • The U.S. Office of Personnel Management has released its Fiscal Year 2027 Congressional Budget Justification.
    • Worth noting on page 84
      • The FEHB Protection Act of 2025 (FPA) requires OPM to strengthen eligibility verification and oversight of the FEHB Program. OPM is directed to issue regulations and implement verification processes by July 4, 2026, conduct a comprehensive family member eligibility audit between July 4, 2026 – July 4, 2029, and establish a process for removal of ineligible individuals (completed in December, 2025 per statutory deadline).
    • FEHBlog observation — Any improvement in eligibility verification should begin with adding the HIPAA 820 electronic enrollment roster transaction to OPM’s enrollment system. That transaction would allow carriers to reconcile premium payments to individual enrollments. What is the sense of performing this family member audit if carriers don’t know if the individual with self and family or self and family coverage (or half of the enrollment with self only coverage) is paying the correct premium?
  • Healthcare Dive reports,
    • “Antitrust regulators are warning Tennessee not to terminate an agreement giving its health department oversight of Ballad Health, a hospital monopoly in the state.
    • “The Tennessee legislature is considering bills that would allow Ballad’s certificate of public advantage, or COPA, to expire in 2028. Balled was formed in 2018 under the COPA, a controversial mechanism that allows potentially anticompetitive hospital mergers to go through in exchange for increased state oversight for a period of time.
    • “Without the COPA, all state supervision of Ballad’s care quality, availability and access, along with population health initiatives, would end.
    • “That could have steep consequences for Tennessee patients, including higher healthcare costs and poorer quality of care, the Federal Trade Commission said in the letter sent Wednesday.”
  • MedTech Dive relates,
    • “The Trump administration is adjusting how Section 232 tariffs on steel, aluminum and copper imports and derivative products are calculated, according to a proclamation President Donald Trump signed Thursday. 
    • “Under the new rules, which go into effect April 6, goods made almost entirely of aluminum, steel or copper, including steel coils and aluminum sheets, will face a 50% tariff for the value of the item. 
    • “However, derivative articles “substantially made” of steel, aluminum or copper will incur a 25% levy, per a White House fact sheet. Such goods include steel cooking appliances, silverware, diesel-engine trains and semi-trailer hauling trucks, according to a list provided by the White House.” 

From the public health, medical / Rx research front,

  • The Washington Post reports,
    • “Uri Alon was long puzzled by a textbook statistic: longevity, the thinking went, was about 20 percent in our genes.>” * * *
    • “The original studies that were used to estimate how much of lifespan was inherited were studies of Scandinavian twins from the tail-end of the 19th century.
    • “During that era, “extrinsic” mortality was high — deaths that aren’t related to the deterioration of aging, such as accidents, violence or deaths from infections that are now uncommon because of better nutrition, therapies and hygiene.
    • “His team examined a database of Swedish twins born later, between 1900 and 1935, and found that these extrinsic deaths were masking the inherited component of lifespan. When they applied their model, designed to remove extrinsic deaths, to databases of Scandinavian twins and the siblings of centenarians who lived to at least 100, the heritability of lifespan markedly increased — to about half.” * * *
    • “Thomas Perls, a longevity researcher at Boston University and the founding director of the New England Centenarian Study, agrees that genetics play a major role in lifespan, but that it depends on what age you are talking about.
    • “At the very extremes of old age — people who live to 105 or even 110 — genetics play a major role in lifespan. But Perls points to a 2018 study in the journal Circulation that suggests that even without winning the genetic lottery, an average person can probably get to about 88 years old as a man, and 93 years old as a woman. That depends on embracing good health-related behaviors. He also notes that socioeconomic advantages contribute — access to health care, education, healthy food.”
  • and
    • “Joseph Buxbaum was initially unconvinced. When early hints of a connection between autism and Alzheimer’s began to appear in the medical literature a few years ago, they struck him as implausible — one a condition of early brain development, the other driving decline in old age.
    • “But the signals kept accumulating, and over time, his skepticism gave way to a new line of inquiry that could transform scientists’ understanding of the two diseases.
    • “I came to this kicking and screaming. I didn’t want to believe it,” Buxbaum, a professor of psychiatry, neuroscience, and genetics/genomic sciences at the Icahn School of Medicine at Mount Sinai, said.” * * *
    • “The idea that two conditions at opposite ends of life might be biologically linked is beginning to upend long-standing assumptions in brain science, blurring a divide that has shaped the field for decades. Now, some researchers have begun to see the two as intertwined: that understanding Alzheimer’s may require looking back to how the brain develops, and that insights into autism might, in turn, reshape how we understand Alzheimer’s itself.”
  • Medscape tells us,
    • “For decades, clinical dietetics has been based on standardized nutritional recommendations for the general population: food pyramids, and Italy’s nutrient reference values, and dietary indications applied uniformly for conditions such as hypercholesterolemia or hypertension.
    • “In routine practice, however, physicians have increasingly observed that patients with the same caloric intake and physical activity can show different outcomes in terms of weight change, glycemic control, or lipid profile.
    • “This interindividual variability, once considered a clinical anomaly, is now supported by scientific literature. Response to diet does not depend exclusively on energy balance but also on a series of individual biological characteristics that influence nutrient metabolism and the interaction between diet and the body’s physiology.”
    • “Precision nutrition frames diet from a simple quantitative tool of nutrients to a personalized metabolic intervention.
    • “Applications of precision nutrition extend beyond body weight management. It has potential relevance in numerous clinical conditions, including gastrointestinal disorders such as irritable bowel syndrome, food intolerances, kidney stones, and various cardiometabolic conditions.”
  • and
    • “Analysis of real-world pharmacovigilance data shows that GLP-1s demonstrate distinct adverse event patterns across indications, primarily related to metabolic, nutritional, gastrointestinal, and psychiatric disorders, with different profiles observed across treatments.” * * *
    • “As millions of patients are taking GLP-1s for weight control and obesity treatment worldwide, clinicians should be vigilant in monitoring for unanticipated long-term adverse effects,” the authors of the study wrote.”
    • “The study was led by David Stone, Departments of Oncological Sciences and Biomedical Informatics, University of Utah, Salt Lake City. It was published online in Obesity.”

From the U.S. healthcare business and artificial intelligence front,

  • Beckers Payer Issues reports,
    • “The Blue Cross Blue Shield Association submitted a wide-ranging letter to CMS on March 30 in response to the agency’s information request on its Comprehensive Regulations to Uncover Suspicious Healthcare, or CRUSH, initiative. 
    • [Three of] Seven BCBSA Recommendations
      • “1. CMS should notify Medicare Advantage plans in real time when it suspends payments to a provider over suspected fraud because bad actors are exploiting the current information gap by shifting billing from original Medicare to MA after CMS acted on suspected fraud in fee-for-service.
      • “2. CMS should remove any contractual or policy language that requires MA plans to continue paying claims when fraud is suspected, regardless of whether CMS has paid its portion. The association also recommends that suspect claims be tagged with a unique code or priced at zero member liability at the time of a CMS payment suspension, so MA plans can identify those claims before payment.” * * *
      • “6. Overall, the association says the independent dispute resolution process under the No Surprises Act is broken and needs structural fixes. BCBSA recommends CMS launch the IDR Gateway as soon as possible, implement baseline eligibility screening before payment or review, establish an upfront eligibility fee to deter bad-faith submissions, and create performance metrics.”
  • The Health Care Cost Institute relates,
    • “The prevalence of depression and anxiety has increased steadily since 2019. Previous research, including a report from HCCI,  has identified a concurrent steady increase in the use of antidepressant and anxiolytic medications. Previous studies have found that most people receive prescriptions for psychotropic medications from their primary care providers. This finding describes national prescribing patterns, but few analyses have examined sub-national patterns and whether there is variation at a state level.” * * *
    • “Nationally, approximately three quarters of antidepressant and anxiolytic prescription fills are prescribed by a primary care provider. The remaining quarter of fills are prescribed by psychiatrists and psychiatric NPs, and a small fraction (<1%) are prescribed by other mental health professionals.” * * *
    • “At the state level, there is variation in the proportion of antidepressant and anxiolytic fills prescribed by each provider type. The proportion of fills prescribed by a PCP range from 55% in Washington, D.C. to nearly 86% in West Virginia.  Likewise, Washington D.C. has the highest proportion of fills prescribed by a psychiatrist or psychiatric NP (44%) while West Virginia has the lowest (14%).  The proportion of prescriptions from other mental health providers is highest in Rhode Island (5%) and lowest in Mississippi (0.2%).”
    • “At a national level, the proportion of antidepressant and anxiolytics prescribed by a psychiatrist or psychiatric NP increased by about 2 percentage points from 2018-2022.”
    • “More research is needed to understand the implications of high levels of PCP prescribing. One study found that patients who are treated by PCPs were less likely to be adherent to antidepressant treatment than patients who are treated by psychiatrists, and that patients treated by multiple providers had lower odds of nonadherence than patients treated by a single provider. Future studies should investigate why patients are receiving antidepressant and anxiolytic prescriptions from PCPs. This phenomenon could be related to mental health provider shortages or could indicate integration of mental health care into primary care, which is an objective of collaborative care models. Additional areas of research should include the role of other mental health providers, including allied health professionals, in prescribing medication, and outcomes associated with these prescribing provider types. Understanding how and why people are prescribed medications to treat mental health conditions is foundational for making informed decisions and effective policy to promote mental health care access.”
  • “The Wall Street Journal explains how a consumer can obtain healthcare advice from a AI tool.  The journalist does so in consultation with a human doctor.”

Friday report

David Ermer–CDC, CMS, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) released its Plan Year 2027 Carrier Call Letter for the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) Programs, outlining a clear shift toward prevention, wellness, and long-term health outcomes.
    • “The guidance calls on FEHB and PSHB carriers to help advance a healthcare approach that prioritizes prevention, improves health outcomes, and supports long-term affordability.
    • “The Plan Year 2027 priorities emphasize empowering individuals to take a more active role in their health while encouraging carriers to expand access to non-pharmaceutical interventions and digital therapeutics, promote cost-effective sites of care, and reduce unnecessary or low-value services. Over time, these changes are expected to prevent chronic conditions and drive meaningful cost savings.
    • “This year’s carrier letter reflects this administration’s commitment to WellCare and prioritizing the health and longevity of federal workers,” OPM Associate Director for Healthcare and Insurance Shane Stevens said. “Today’s health decisions shape outcomes for years to come.  By focusing on prevention and giving individuals the tools to take ownership of their health our participants have enhanced opportunities to improve their health while ensuring a more sustainable program for federal employees, retirees, and taxpayers.”
    • “OPM will continue working with carriers to implement these changes and strengthen a healthcare system centered on wellness and prevention. Read the letter to carriers here.”
  • FEHBlog Observation — While the call letter does include a boatload of new mandates, those mandates sit on topic of ideas from the Obama and Biden administrations because OPM rarely looks back. It’s high time to offset new spending by cleaning house on earlier mandates.
  • The American Hospital Association reports,
    • “President Trump April 3 submitted to Congress his budget request for fiscal year 2027. The top-line request proposes a 10% decrease ($73 billion) in non-defense discretionary spending. The budget requests $111.1 billion in discretionary funding for the Department of Health and Human Services, a 12.5% ($15.8 billion) reduction from FY 2026 enacted. The HHS proposal does not include any new mandatory spending proposals. While this proposal is not binding, it serves as a preliminary framework for both Congress and the administration as they determine federal funding levels and shape health care policy this year.”  
  • STAT News relates,
    • “The Trump administration is slashing the number of quality and care measures that Medicare Advantage plans will be graded on, a move that will funnel an extra $18.6 billion toward health insurers over the next decade.
    • “The final regulation, released Thursday by President Trump’s Centers for Medicare and Medicaid Services, is significantly more beneficial for the insurance industry than originally expected. CMS previously estimated these changes to star ratings would cost $13.2 billion between 2028 and 2036 when the rule was proposed in November.
    • “The extra funding from star ratings provides a sizable buffer for Medicare Advantage insurers, which are awaiting final payment rates for 2027 and experiencing higher medical claims. Insurers have lobbied Trump officials for more money in their baseline payments, and to scale back changes in how they record the sicknesses of their members. The government is supposed to release that regulation no later than April 6.”
  • Bloomberg Law adds,
    • “President Donald Trump’s plan to cover weight-loss medications for some people in the Medicare program for the elderly would cost the health insurers billions in its first year, a new analysis found. 
    • “The Trump administration has argued that the lower prices it negotiated with drugmakers last year would offset the cost of adding coverage for millions of new patients. The plan will “expand access and lower prices for obesity GLP-1 medication without passing the bill to taxpayers,” Mehmet Oz, director of the Centers for Medicare and Medicaid Services, said in a video promoting the plan. 
    • “But a new analysis undercuts that claim. Savings of more than $900 million during the program’s first year would only cover the costs for an estimated 4.4% of the patients who would become newly eligible for the drugs, according to researchers led by Vanderbilt University Professor of Health Policy Stacie Dusetzina.
    • “The findings published in the Journal of the American Medical Association come ahead of a crucial April 20 deadline for health insurers to decide whether they will join the optional program next year. The Trump administration has said it won’t proceed with the plan unless insurers covering 80% of the Medicare population join.
    • “All of the major insurers participating in Medicare’s drug benefit program would need to opt-in to hit that threshold. Dusetzina said she doesn’t see any clear path for the plans to increase access without a significant financial hit.”
  • FEHBlog Observation: This Medicare program would benefit the FEHB and PSHBP which currently covers these GLP-1 drug expenses for federal and Postal annuitants over age 65.
  • Fierce Pharma notes,
    • “The U.K. can officially declare itself free of tariffs on drug exports to the U.S. after its government signed off on the landmark U.S.- U.K. pharmaceutical partnership that first came to be in December. 
    • “In exchange for the tariff reprieve, the U.K. will boost the net price its National Health Service (NHS) pays for novel treatments by 25%. The arrangement lasts at least three years and makes the U.K. the first in the world to secure 0% tariffs on U.S. pharma exports, U.K. officials said in a Thursday press release. 
    • “First announced in December, the partnership protects a UK pharmaceutical industry that added £28.5 billion to the UK economy in 2025, employs over 50,000 people in highly skilled, well-paid jobs, and exported almost £21 billion in pharmaceutical products worldwide last year,” the government explained.” 

From the public health, medical and Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “US flu activity keeps trending downward, according to the latest FluView report from the Centers for Disease Control and Prevention (CDC).
    • “Flu cases are declining across most of the country, the CDC said, with influenza A viruses waning and influenza B viruses showing varying levels of activity. That trend follows the typical seasonal flu virus patterns. The proportion of tests that were positive for flu fell to 9.8%, down from 11.5% the previous week, and the proportion of outpatient visits for flu remained below the national baseline for the second straight week, falling from 2.8% to 2.6%.
    • “For the season overall, influenza A viruses have been the most frequently reported. Of the influenza A viruses collected so far, 92.7% have belonged subclade K, which contains mutations that developed after this season’s flu vaccine strains were selected.
    • “Weekly hospital admissions for flu also declined, dropping from 5,640 the previous week to 3,050 this week. But an additional four pediatric deaths were reported this week, bringing the total for the season to 127. Although the CDC has classified the current flu season as moderate for adults, for children it’s been a high severity season.
    • “The CDC estimates there have been 30 million illnesses, 370,000 hospitalizations, and 23,000 deaths from flu so far this season.”
    • “Overall, the amount of acute respiratory illness causing Americans to seek health care is low, the CDC said in its respiratory illness update. But respiratory syncytial virus (RSV) activity picked up later than normal this year and is currently at elevated levels, though it appears to have peaked in most regions, and the virus isn’t making people sicker than in previous seasons. Emergency department visits and hospitalizations for RSV are highest among children aged 4 and under.
    • “COVID-19 levels are low across most of the country.
    • “The CDC also noted that human metapneumovirus (HMPV) activity is rising across the country, which is typical for this time of year. Symptoms of HMPV include cough, fever, nasal congestion, and shortness of breath.“
  • Beckers Clinicial Leadership adds,
    • “The new “Cicada” variant identified in more than half of U.S. states may be more likely to infect children than adults, CNN reported April 2.
    • “The variant, BA.3.2, earned its nickname because it has largely remained undetected or “underground” — like its insect namesake — since first discovered in a five-year-old boy in South Africa in November 2024.” 
  • The American Hospital Association relates,
    • “Cases in the Utah measles outbreak have increased to 559, the state’s Department of Health and Human Services reported March 31. The agency said 362 cases have been diagnosed so far this year during the outbreak, which began in June 2025. The Centers for Disease Control and Prevention reported today that there are 1,671 measles cases nationwide across 33 jurisdictions. There have been 17 outbreaks reported this year, with 94% of confirmed cases being outbreak-associated. The vaccination status of 92% of cases is unvaccinated or unknown.” 
  • KFF Health News points out,
    • “This week, the Centers for Disease Control and Prevention posted online its first large tranche of advanced genetic data from measles viruses spreading last year. Scientists with knowledge of the operation expect the agency to post heaps more in weeks to come, revealing whether the U.S. has lost its hard-won measles elimination status.” * * *
    • “The CDC did not answer queries from KFF Health News on its timeline for publishing measles data or analyses. However, once all the data is public, researchers can run quick initial analyses that will signal whether outbreaks across the U.S. last year resulted from the continuous spread of the disease between states, rather than separate introductions from abroad.
    • “If there was continuous transmission for a year, that means the U.S. has lost its status as a country that has eliminated measles. That status, which the U.S. has held since 2000, reflects a country’s vaccination rates: Two doses of the measles-mumps-rubella vaccine prevent most infections and so stop outbreaks from growing.
    • “More careful analyses take weeks.”
  • Reuters tells us,
    • “Medetomidine, which is also known as ‘rhino tranq,’ or ‘dex’, is ​not approved for human use but is approved for sedation ​and analgesia in dogs.
    • “The agencies said it has increasingly been detected in law enforcement drug seizures, drug product and paraphernalia samples and wastewater samples, ​with the highest concentrations in the Northeast region.
    • “The CDC said ​stopping medetomidine after regular use can trigger severe withdrawal, with symptoms including hypertension, ‌anxiety, ⁠nausea, vomiting and fluctuating alertness, which may require emergency or intensive care. It can also cause profound sedation, slow heart rate and hypotension.
    • “Because fentanyl is involved in most overdoses involving medetomidine, opioid ​overdose reversal medications ​like naloxone ⁠should be administered to restore normal breathing, the agencies said.”
  • Health Day tells us,
    • “A new rapid urine test could lead to more targeted and effective treatment of urinary tract infections (UTI), researchers say.
    • “It currently takes labs two to three days to determine which antibiotic would work best against an individual’s UTI.
    • “But the new test can turn around results in just under six hours, creating the potential for same-day antibiotic prescriptions for a UTI, researchers reported in this month’s issue of the Journal of Antimicrobial Chemotherapy.”
  • Medscape informs us,
    • “A group of diabetes professionals is proposing a change from the term prediabetes to the use of a three-stage classification of type 2 diabetes (T2D), with the aim of promoting earlier treatment and risk reduction.
    • “When is it too early to start to intervene in the process of diabetes?” said Moshe Phillip, MD, director of the Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children’s Medical Center, Petah Tikva, Israel, co-author of a comment paper on the topic published earlier this year in the Lancet Diabetes & Endocrinology.
    • “One of the mistakes that “we as a community have done in the past” is to label people as having prediabetes “because ‘prediabetes’ means that you are healthy,” he told Medscape Medical News.
    • “Actually, many of those that are defined as having prediabetes have a higher risk for all complications, mainly cardiovascular, he explained.” * * *
    • “Yet there is no drug approval process for prediabetes, despite the evidence that agents such as metformin, pioglitazone, and GLP-1 drugs can prevent progression to T2D and reduce cardiovascular risk.”

From the U.S. healthcare business and artificial intelligence front,

  • Modern Healthcare reports
    • “Elevance Health will apply its policy deducting pay from hospitals that refer some members to out-of-network providers to facilities in New York.
    • “Starting July 1, Elevance Health’s Anthem Blue Cross Blue Shield subsidiary may reduce New York hospitals’ pay by 7.5% or terminate facilities from its network if hospitals refer commercial members to inpatient or outpatient providers without a contract.
    • “Hospitals cannot pass the monetary penalty onto patients, according to an April 1 notice sent to providers.
    • “Rural, critical access and safety-net hospitals are exempt. Hospitals will also not be penalized for referring patients to emergency services or an out-of-network pre-approved provider. Additionally, the penalty will not apply when no in-network providers are available to provide the same care within the same geographic area.”
  • Healthcare Dive offers a commentary from Dr. Catherine Gaffigan is the president of health solutions at Elevance Health in which Dr. Gaffigan explains how this practice holds down health care costs.
  • Medical Economics relates,
    • “Medical Economics spoke with Shannon Sims, M.D., Ph.D., FAMIA, chief product officer at Vizient, and Matthew Bates, M.P.H., managing director at Kaufman Hall, about Vizient’s 2026 State of the Industry Report and what it describes as a reset moment for U.S. health care. When asked what changes physicians will feel first, both pointed to the same two shifts: artificial intelligence (AI) moving into everyday workflow and advanced practice providers (APPs) taking on a larger share of clinical care.
    • “Bates framed the AI transition as a move out of the hype cycle and into practical use. Ambient listening — tools that generate clinical notes from recorded patient encounters — is the clearest example. “It is moving from a niche to really changing the way we practice, particularly in clinic and office settings,” Bates said.
    • “Sims explained that, “what most physicians will see day to day is the use of AI tools to automate or reduce the burdens they feel,” pointing specifically to documentation, billing, medication refills and patient access as areas where meaningful improvement is already within reach. Now, he says the window for sitting it out is closing. “If [physicians] do not [embrace these tools], they risk falling behind and losing some of the relevance and ability to practice in the way they would like to.”
    • “On APPs, Bates was equally blunt. The physician shortage is real, it isn’t resolving quickly, and APPs are filling the gap. How health systems build effective, high-quality teams around that reality, rather than just plugging holes, is one of the central operational questions of the moment.”
  • Radiology Business adds,
    • “A Harvard University economist claims that imaging volumes are falling in the U.S., blunting the need for more radiologists. 
    • “David M. Cutler, PhD, a noted researcher and professor, shared the thought in an editorial published Thursday by JAMA Health Forum. He cited research including 2019 study published by the Radiological Society of North America showing that imaging use stabilized or declined between 2010 and 2016.
    • “Dipping utilization combined with lower reimbursement per procedure has led to a “sustained slowdown in imaging spending growth,” Cutler wrote. 
    • “In addition to helping with cost concerns, the reduction in imaging use has helped to minimize a potential shortage of radiologists,” he wrote April 2. “For some time, economists were worried about a looming radiologist shortage. The decrease in imaging has allowed the U.S. to meet the need for imaging without an increase in radiologists.”
    • “The claims appear to contradict both anecdotal and numerous published academic reports stating the contrary. Another RSNA-published study last year found that emergency departments’ use of CT imaging has increased substantially since 2013. Another JACR study published in January estimated that radiology exam caseloads climbed 31% since 2018. A third shared by Health Affairs in 2024 said overall spending on radiology services leapt almost 36% between 2010 and 2021.”  

Notable Death

  • The Wall Street Journal reports,
    • “By the time patients seek therapy for post-traumatic stress disorder, many have spent years suppressing their worst memories and avoiding the places and situations they associate with the most difficult moments of their lives. 
    • “Edna Foa asked them to get closer to those moments.
    • “She asked women who had survived rape to recount what happened, and encouraged soldiers to explain what they had seen in war. It wasn’t an easy ask, but patients had been avoiding so many things for so long that their worlds had gotten smaller and many were willing to try something, even if it felt drastic. 
    • “At first, revisiting memories and places that they feared could be distressing. Over time—typically eight to 15 sessions—the prolonged exposure therapy could make the memories of the traumatic events approachable and turn them into something they could emotionally process and ultimately take power over.
    • “Foa, a clinical psychologist who died March 24 at the age of 88, didn’t just pioneer prolonged exposure therapy, one of the most effective, evidence-based therapies used for treating PTSD in the U.S.; she also created an ecosystem to get it into practice. She trained thousands of healthcare professionals on how to treat patients, and trained others how to do the training. She also wrote books, manuals and patient workbooks to make sure that the training was implemented correctly.”
  • RIP

Thursday report

David Ermer–CDC, CMS, Congress, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

From Washington, DC

  • Govexec reports,
    • “President Trump on Thursday said he plans to sign an executive order to pay all Homeland Security Department workers, after the House failed again to pass legislation ending the partial government shutdown, now in its 48th day.” * * *
    • “TSA workers were granted four weeks’ worth of back pay Monday following the signing of the more targeted edict last week, while ICE and CBP workers have been paid on time since the beginning of the department-wide appropriations lapse using funds from the One Big Beautiful Bill law. Still working without pay within the department are employees at the Federal Emergency Management Agency along with support staff and other non-immigration-related DHS components. 
    • “Observers had anticipated Thursday to serve as the potential end of the six-week impasse. After the House rejected a Senate-passed bill to fund DHS—minus ICE and CBP—through the end of September last week, senators again passed the bill with the expectation that the House would approve it via unanimous consent that morning. But when the House convened its pro forma session, lawmakers did not bring the measure up for consideration, reportedly due to pressure from conservative GOP members.
    • “The next possible opportunity for Speaker Mike Johnson to advance the DHS legislation would be Monday. The House is not set to return to Washington until April 14.”
  • Roll Call relates,
    • “President Donald Trump ousted Pamela Bondi as attorney general Thursday, closing out a tumultuous tenure punctuated by rolling controversies and attacks against the Justice Department’s traditional independence from the White House.
    • “Trump, who made the announcement in a social media post, said his former personal attorney, Deputy Attorney General Todd Blanche, would lead the department as acting attorney general. The president described Bondi as a “loyal friend.”
    • “Bondi, in a statement on social media, said that over the next month she would be working to transition the office of attorney general to Blanche “before moving to an important private sector role.”
    • “She said she would continue “fighting for President Trump and this Administration” in the new role.”
  • The Wall Street Journal tells us,
    • “The U.S. will impose tariffs of as much as 100% on branded pharmaceuticals, the White House said Thursday, though nations or drugmakers that strike deals with the Trump administration or commit to build manufacturing facilities in the U.S. can receive lower levies. 
    • “The 100% tariff will apply to patented imported pharmaceuticals from companies that haven’t committed to invest in the U.S. and haven’t entered into “most favored nation” agreements to match their U.S. prices to the lowest they charge in other developed countries, a senior administration official said Thursday.
    • “But the full 100% tariff might apply to only a few drugmakers or none at all. If a company pledges to invest in U.S. drug manufacturing in the coming years, its tariff rate will fall to 20%, the senior administration official said. The company would have to complete the factory by the end of President Trump’s term in the White House, the official said, or tariffs could be increased.
    • “Additionally, if a company that has made a U.S. manufacturing pledge also strikes a most-favored-nation agreement with the Trump administration, its tariffs can fall to zero, the official said.”
  • Lotsa Medicare news today. Bloomberg Law reports,
    • “The Trump administration announced changes to patient cost-sharing in Medicare’s prescription drug benefit and will update the methodology used to rate private Medicare Advantage plans.
    • “The final rule (RIN 0938-AV63), released Thursday by the Centers for Medicare & Medicaid Services, implements changes to Part D enacted under the Inflation Reduction Act in 2022 and will update the methodology used to calculate insurers’ “star ratings,” which are quality scores that determine bonuses and marketing privileges. The changes would take effect in 2027.
    • “The new rule finalizes the Inflation Reduction Act’s elimination of Medicare Part D’s coverage gap as part of a broader overhaul of how the program is financed. The law’s $2,000 annual out-of-pocket cap for prescription drugs took effect last year.
    • “The agency chose to hold off on finalizing a previous proposal that would have allowed Medicare Advantage members a special enrollment period when their doctor leaves their network.”
  • and
    • “The Trump administration proposed new transparency measures for hospices under Medicare amid a focus on fraud led by Centers for Medicare & Medicaid Services Administrator Mehmet Oz.
    • “The proposed rule (RIN 0938-AV78), released Thursday by the CMS, also includes updates to the hospice wage index, which adjusts daily Medicare hospice payments based on differences in labor costs across geographic regions. 
    • “The measure proposes a new analysis of non-hospice spending in an effort to better identify fraud and overutilization, as well as to require hospices to list for patients what services are not covered under Medicare’s hospice benefit.
    • “Hospices exist to help Americans die peaceful, dignified deaths, not to line the pockets of fraudsters,” Oz said in a statement. “These new transparency measures will make it easier for CMS and others to identify hospice providers that misuse Medicare dollars, cut off their funding, and refer them to law enforcement for criminal prosecution.”
    • “The proposal would also increase payment rates in fiscal year 2027 by 2.4%, or $785 million, and seeks comment on developing a hospice-specific wage index.”
  • The American Hospital Association News informs us,
    • The Centers for Medicare & Medicaid Services April 2 issued a proposed rule for the skilled nursing facility prospective payment system for fiscal year 2027. The proposal would increase aggregate payments by 2.4%, which reflects a 3.2% market basket update and a 0.8 percentage point cut for productivity. CMS also included in this proposed rule a request for information on how to address perceived case-mix upcoding. For the SNF Quality Reporting Program, CMS proposes to remove two measures focused on COVID-19 vaccination for patients and health care personnel. CMS also proposes to shorten the timeframe for data submission at the end of each quarter from 4.5 months to 45 days beginning with FY 2029. CMS suggests this change would reduce the lag in public reporting and give SNFs access to more timely data for quality initiatives. CMS will accept public comments on the proposed rule through June 1, 2026. 
  • and
    • The Centers for Medicare & Medicaid Services April 1 released the fiscal year 2027 prospective payment system proposed rule for inpatient rehabilitation facilities. The rule would increase payments by 2.8% overall, which includes a 3.2% market basket update, reduced by a 0.8 percentage point productivity adjustment. CMS is also proposing a slight decrease in the outlier threshold, which would increase payments by 0.4 percentage points. Further, CMS proposes changes and clarifications to the IRF coverage rules, including that all therapies must be initiated within 36 hours of admission to the IRF, current functional status be documented at admission, and the initial interdisciplinary team meeting occur on or before the fourth day of admission. Finally, CMS has also included a request for information on modernizing the IRF PPS, including more closely aligning methodologies with those used for skilled nursing facilities. 
  • and
    • “The Centers for Medicare & Medicaid Services April 2 issued a proposed rule for the inpatient psychiatric facility prospective payment system for fiscal year 2027. CMS proposes to increase IPF payments by a net 2.3%, equivalent to $50 million, in FY 2027. The payment update reflects a proposed market basket update of 3.1% minus a productivity adjustment of 0.8 percentage points. CMS also proposes to update the outlier threshold so that estimated outlier payments remain at 2.0% of total payments. 
    • “For the IPF Quality Reporting Program, CMS proposes to remove two measures focused on alcohol and tobacco use screening and treatment effective with the calendar year 2026 reporting/FY 2028 payment periods. CMS also proposes to implement the standardized IPF Patient Assessment Instrument that is mandated by the Consolidated Appropriations Act of 2023. IPFs would be required to collect IPF-PAI data on all patients age 18 years and older regardless of payer beginning Oct. 1, 2027. CMS will accept public comments on this rule through June 1.”
  • and
    • “The Centers for Medicare & Medicaid Services March 31 released a request for applications for its new accountable care organization model, the Long-term Enhanced ACO Design Model, or LEAD. The model is designed to accommodate a wide range of health care providers, including those who have not previously participated in an ACO and providers who care for specialized patient populations. CMS said ACOs interested in the voluntary, 10-year payment model must apply by May 17. The model will launch Jan. 1, 2027.” 
  • Tammy Flanagan writing in Govexec asks “Traveling soon? What federal health plans actually cover.”
    • “Peak travel season is here, but most federal workers don’t know what happens if they need care abroad. From upfront costs to medical evacuations, here is what your FEHB plan does and doesn’t cover when you are out of the country.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced a cross-government hiring action to recruit Project Managers for critical roles across federal agencies.
    • “Project management has long been identified as an area where the federal government faces a critical skills gap. OPM is tackling that skills gap with this cross-government hiring action. Selected candidates will lead major initiatives in areas such as artificial intelligence, healthcare, defense, energy, financial technology, and infrastructure, increasing on-time, on-budget delivery through professionalized project management practices. Applicants will be screened for qualifications and must complete project management and writing assessments to determine skills levels.
    • “Like the Tech Force program, OPM will use a shared certificate allowing several agencies to hire qualified candidates from the same pool for one year. The effort supports a goal to hire about 250 professionals in project management and data science roles across government.
    • “Delivering on complex national priorities requires strong project management at every level of government,” OPM Director Scott Kupor said. “This effort helps agencies identify and hire professionals who can drive execution, manage risk, and ensure results for the American people.”
    • “Click here to view the job posting and contact CrossGovHiring@opm.gov for more information.”
  • Per an ARPA-H news release,
    • “New STOMP program will uncover how microplastics build up in the body—and drive new ways to protect people from their potential health impact
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced STOMP: Systematic Targeting Of MicroPlastics, a nationwide $144 million program to create the definitive toolbox for measuring, researching, and affordably removing microplastics and nanoplastics (MNPs) in the human body. 
    • “Today, HHS is taking decisive action to confront microplastics as a growing threat to human health,” said HHS Secretary Robert F. Kennedy, Jr. “Americans deserve clear answers about how microplastics in their bodies affect their health. Through ARPA-H’s STOMP program, we will measure microplastic exposure, identify sources of risk, and develop targeted solutions to reduce it.”  

From the judicial front,

  • Thompson Reuters reports,
    • “Whittemore v. Cigna Health & Life Ins. Co., 2026 WL 777418 (1st Cir. 2026)
    • “The First Circuit has affirmed the dismissal of a lawsuit challenging a health plan’s exclusion of weight-loss drugs, holding that a participant did not plausibly allege she had a disability simply by stating she had been diagnosed with obesity and prescribed medication to treat it. The participant filed a proposed class action lawsuit against a health insurer, alleging disability discrimination under Affordable Care Act (ACA) Section 1557. The participant asserted that her obesity was a disability and that the insurer discriminated against her by designing and administering health plans that categorically excluded coverage for prescription weight-loss medications. (Section 1557 prohibits discrimination on grounds specified in several federal laws, including Section 504 of the Rehabilitation Act, which bars discrimination based on disability.) The district court dismissed the case, ruling that the participant had not plausibly shown that she was disabled merely as a function of her body mass index, nor that the insurer had ever regarded her as disabled.
    • “The First Circuit affirmed the dismissal, but on different grounds. The court explained that to state a disability discrimination claim, the participant had to show she was disabled as defined by the Americans with Disabilities Act (ADA). The ADA defines disability as a physical or mental impairment that “substantially limits one or more major life activities.” The participant’s complaint alleged that her obesity substantially limited her in major life activities such as walking, standing, and sleeping. The court, however, concluded that these allegations were conclusory “threadbare recitals of the elements of a cause of action.” The court also rejected the participant’s argument that any individual diagnosed with obesity and prescribed medication for it is, by definition, substantially limited in the operation of major bodily functions, reasoning that such general statements about obesity’s potential health impacts do not plausibly support an inference that every person in that category is disabled under the ADA.”

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “Flu and COVID-19 vaccination rates among all health care workers for the 2024-25 respiratory virus season was 76.3% and 40.2%, respectively, according to a Centers for Disease Control and Prevention report released April 2. Coverage was higher for personnel whose employers offered on-site flu and COVID-19 vaccinations, at 73% and 42.9%. Lower figures were found among personnel with employers that did not offer on-site vaccinations, at 41.4% and 19.8%. The CDC said that increasing vaccination coverage by implementing workplace policies, including offering on-site vaccinations, could increase coverage and reduce flu- and COVID-19-related morbidity among health care providers.” 
  • The University of Minnesota CIDRAP adds,
    • “Respiratory syncytial virus (RSV) vaccination coverage among older US adults remained low through the end of the 2024–25 respiratory virus season, according to a new study published in Vaccine. In 2024, the Advisory Committee on Immunization Practices recommended RSV vaccination for adults aged 60 to 74 years who are at increased risk of severe RSV and for all adults aged ≥ 75 years.
    • “Analyzing data from approximately 64,000 adults surveyed from September 2024 through April 2025, researchers from the Centers for Disease Control and Prevention found that, by the end of the 2024–25 respiratory virus season, 38.3% of adults ages 60 to 74 who were at increased risk of severe RSV and 41.5% of those 75 and older had received an RSV vaccine.”
  • Cardiovascular Business shares “Key clinical takeaways from ACC.26” * * * “in New Orleans highlighted advances that will likely impact patient care for years to come. Key topics included pulmonary embolism (PE), lipid management and noninvasive coronary assessment.”
  • Genetic Engineering and Biotechnology News relates,
    • “The ALS Therapy Development Institute (ALS TDI), LifeArc, and Axol Bioscience launched the Patient induced pluripotent stem cell (iPSC)-based Research to Improve Sporadic ALS Modeling (PRISM) initiative, a collaborative effort to expand access to patient-derived stem cell models.
    • ‘ALS is a heterogeneous disease. While 10-15% of cases are linked to inherited mutations, nearly 85% are sporadic, according to a PRISM ALS official, who adds that much of ALS drug discovery has relied on models representing a limited number of rare genetic subtypes. This mismatch has constrained target discovery, limited therapeutic testing across patient populations, and contributed to the high failure rate of clinical trials, maintains the spokesperson.
    • “This initiative plans to provide a high-quality and accessible source of sporadic ALS/MND models for use in research. PRISM ALS aims to develop, evaluate, and make available a diverse panel of well-characterized, patient-derived induced pluripotent stem cell (iPSC) models that capture both genetic and sporadic forms of ALS.
    • “For researchers and drug developers, those standardized, human-relevant models are expected to allow them to better understand disease mechanisms, identify therapeutic targets, and evaluate treatments across distinct biological subtypes. For people living with ALS, it might lead to the development and testing of therapies in models that more closely mirror their own biology, increasing the likelihood that discoveries will translate into meaningful treatments.”
  • Per Healio,
    • ‘A short walk around the block, a 30-minute bike ride, or an intense 1-hour lifting session at the gym each can benefit patients with breast cancer undergoing chemotherapy.
    • “A meta-analysis of more than 20 clinical trials showed women randomly assigned to exercise interventions, whether aerobic, strength or a combination of both, during treatment had more than a 60% greater likelihood of reporting improved quality of life than those who received standard care alone.”
  • Per Fierce Pharma,
    • “Another green light appears increasingly within reach for AstraZeneca’s Emerald program after a combo regimen featuring the company’s immunotherapy duo, Imfinzi and Imjudo, showed benefit in certain liver cancer patients. 
    • “Results from the phase 3 Emerald-3 trial showed that the combination, paired with transarterial chemoembolizaton (TACE) and Lenvima, significantly improved progression-free survival (PFS) versus TACE alone in patients with unresectable locoregional hepatocellular carcinoma. Lenvima is a multikinase inhibitor sold by Merck & Co. and Eisai.
    • ‘But whether AZ has struck gold with Emerald-3 remains to be seen. Overall survival (OS), a secondary endpoint that will be a key consideration for the FDA, was immature at the interim analysis, although AZ highlighted a trend toward improvement in its April 2 announcement.”

From the U.S. healthcare business and artificial intelligence front,

  • Modern Healthcare reports,
    • “Henry Ford Health is adding to its rapid expansion across Southeast Michigan with the acquisition of Clinton Township-based Cornerstone Medical Group. 
    • “Terms of the deal were not disclosed, but Cornerstone’s 25 locations across the region will be rolled into Henry Ford Medical Group, which employs 3,400 physicians and researchers.
    • “The locations — which include family and internal medicine, pediatrics, endocrinology, hospitalist care, podiatry and colorectal surgery — have been renamed Henry Ford Cornerstone.”
  • Radiology Business point out.
    • nterventional radiology vendor Merit Medical is acquiring a rival imaging-focused firm for $140 million, the two announced Wednesday. 
    • The South Jordan, Utah-based company plans to merge with View Point Medical, which manufactures the OneMark Detection Imaging System. Cleared by the U.S. Food and Drug Administration in 2024, the device uses ultrasound guidance to detect and remove cancer. 
    • Merit Medical—a leading manufacturer of disposable devices such as catheters and guide wires—said it made the move to help expand its portfolio of therapeutic oncology products. 
    • View Point’s ultrasound-based technology is “highly innovative,” it noted, allowing physicians to localize more lesions at the time of biopsy. This represents a market opportunity of 1.3 million procedures annually in the U.S. alone, Merit estimated. 
  • and
    • “The chief executive of America’s largest public hospital system says he is prepared to start replacing radiologists with artificial intelligence in some circumstances, once the regulatory landscape catches up. 
    • ‘Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, recently spoke during a panel discussion held by Crain’s New York Business. The trained internal medicine specialist noted how AI is increasingly being used to interpret mammograms and X-rays. 
    • “This presents an opportunity to save on how much hospitals spend on radiologists, who have become more costly amid rising demand for imaging, Crain’s reported Thursday. 
    • “We could replace a great deal of radiologists with AI at this moment, if we are ready to do the regulatory challenge,” Katz said at the forum, held on March 25.” 
  • Healthcare Dive relates,
    • “Community Health Systems has closed the sale of another hospital as the for-profit health system makes progress paying down its debt.
    • “On Wednesday, nonprofit Huntsville Hospital Health System acquired Huntsville, Alabama-based Crestwood Medical Center from CHS for $459 million.
    • “The purchase price is higher than the initial $450 million deal proposed in January, when the two health systems signed a definitive agreement. The final amount was subject to a post-closing working capital adjustment, according to a release, an amount that can fluctuate based on the acquisition target’s assets and liabilities.”
  • Beckers Hospital Review tells us,
    • “Oakland, Calif.-based Kaiser Permanente has broken ground on a new hospital tower at Kaiser Permanente Sunnyside Medical Center in Clackamas, Ore.
    • “The seven-story, 615,000-square-foot tower is slated to open in 2029 and will be Oregon’s first fully electric hospital, according to an April 2 health system news release. The facility is also targeting LEED Gold certification and will become Kaiser Permanente’s 87th LEED-certified building.
    • “Features will include private patient rooms; in-room telemedicine capabilities, advanced robotics and image-guided surgical equipment; expanded emergency department capacity to reduce wait times; and green spaces, walking paths and healing gardens.”
  • and
    • “Farmington, Conn.-based UConn Health has shared plans to integrate Middletown, Conn.-based Solnit Hospital, a children and adolescent psychiatric facility, into a satellite location of its UConn John Dempsey Hospital in Farmington.
    • “This collaboration reflects our shared commitment to delivering exceptional, high-quality, and specialized care for Connecticut’s youth while optimizing resources across agencies,” UConn Health CEO, Andrew Agwunobi, MD, said in an April 2 statement shared with Becker’s. 
    • “Solnit Hospital is a state-administered psychiatric facility for children ages 13 to 17. It offers care to children and adolescents with “severe mental illness and related behavioral and emotional problems who cannot be safely assessed or treated in a less restrictive setting,” according to  the state’s website.” 
  • Fierce Healthcare informs us,
    • “Sunfish, a family-building software platform, is launching what it says is the first AI-powered egg-freezing success program in the fertility space.
    • “The goal of the program is to solve the uncertainty that comes with fertility preservation, from a lack of financial transparency to outcomes that are unknown and not guaranteed. Based on a patient’s biodata, Sunfish’s proprietary algorithm predicts the optimal amount of matured eggs that should be frozen as well as the cost of the cycle. 
    • “Sunfish is really focused on helping people to navigate the full fertility journey,” Angela Rastegar, co-founder and CEO of Sunfish, told Fierce Healthcare in an advanced interview. “Patients shouldn’t have to be an unpaid project manager for their own family planning.” 

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, NIH, No Surprises Act, OPM, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Trump on Wednesday endorsed a two-part plan to quickly fund most of the Department of Homeland Security and then use a special procedure to pay for immigration enforcement with only GOP votes, stepping in to resolve a standoff between Republican congressional leaders.” * * *
    • “Congress could now pass a bill funding most of DHS that the Senate approved last week, and Trump set a goal of June 1 for funding the rest of the department using a process called budget reconciliation. The maneuver requires a simple majority for budget-focused bills, rather than the 60 votes typically required in the Senate, which Republicans control 53-47.
    • [Senate Majority Leader John] Thune [(R., SD)] and House Speaker Mike Johnson (R., La.), who had publicly disagreed over the best way to end the DHS shutdown, issued a joint statement backing Trump’s directive and saying they agreed on the two-step path to fully fund the department in “coming days.”
  • Healthcare Dive reports,
    • “Elevance avoided steep sanctions against its Medicare Advantage plans that were set to kick in on Wednesday, after the CMS granted the insurer an extension to make up for incorrect risk adjustment data reporting stretching back years.
    • “Earlier this year, the CMS notified Elevance that it planned to prevent the insurer’s MA plans from enrolling new members, along with other sanctions, starting on March 31 after finding that Elevance failed to comply with federal data submission requirements. Elevance asked regulators for more time to comply, and the CMS granted the company’s request in mid-March, according to a disclosure from Elevance.
    • “Elevance now has until May 30 to correct its data reporting before sanctions kick in. The CMS also exempted several of Elevance’s MA plans that weren’t impacted by the noncompliance from the potential penalties.”
  • The Labor Department issued a “Frequently Asked Question (FAQ) regarding implementation of certain provisions of Title I (the No Surprises Act)(1) of division BB of the Consolidated Appropriations Act, 2021. This FAQ has been prepared jointly by the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM).”
    • The FAQ 73 concerns an ongoing Qualifying Payment Amount dispute long pending before the U.S. Court of Appeals for the Fifth Circuit.
    • “Q1: Are the Departments and OPM extending the enforcement relief regarding the use of QPAs announced in FAQs Part 71?
      • “Yes. The Departments and OPM extend the exercise of enforcement discretion, originally provided in FAQs Part 62 and extended in FAQs Parts 67, 69, and 71, under the relevant No Surprises Act provisions for any plan or issuer, or party to a payment dispute in the Federal IDR process, that uses a QPA calculated in accordance with the 2021 methodology, for items and services furnished on or after February 1, 2026, and before October 1, 2026, the first day of the calendar month that begins after 6 months from the issuance of these FAQs. This exercise of enforcement discretion applies to QPAs for purposes of calculating patient cost sharing, providing required disclosures with an initial payment or notice of denial of payment,(14) and providing required disclosures and submissions under the Federal IDR process.
      • “HHS similarly extends its exercise of enforcement discretion under the relevant No Surprises Act provisions for a provider, facility, or provider of air ambulance services that bills, or holds liable, a participant, beneficiary, or enrollee for a cost-sharing amount based on a QPA calculated in accordance with the 2021 methodology, for items and services furnished on or after February 1, 2026, and before October 1, 2026.”
  • Per an OPM March 31, 2026, news release,
    • “Today, the Office of Personnel Management (OPM) announced the President’s Commission on White House Fellowships is now accepting applications for the 2026-27 class of White House Fellows.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS), through the CMS Innovation Center, announced that organizations participating in certain Innovation Center models may begin offering a new Substance Access Beneficiary Engagement Incentive (BEI) starting April 1, 2026. Through this optional incentive, eligible hemp-derived products can be incorporated into patient care plans under clinician guidance, consistent with model requirements and applicable law.
    • “This milestone reflects the Administration’s broader efforts to expand access to innovative, patient-centered care. It also aligns with President Trump’s Executive Order supporting research and innovation related to hemp-derived products. It marks a meaningful step as CMS begins testing how emerging care tools can be integrated into coordinated care to improve outcomes and quality of life. 
    • “CMS is committed to innovation that meets patients where they are while maintaining strong safeguards and clinical oversight,” said CMS Administrator Dr. Mehmet Oz. “Under the President’s leadership, we’re expanding the tools available to improve patients’ health while generating important insights into how providers can use these tools safely and effectively in real-world care settings.” * * *
    • “More information about the Substance Access Beneficiary Engagement Incentive, including eligibility criteria and program requirements, is available at: https://www.cms.gov/priorities/innovation/substance-access-beneficiary-engagement-incentive.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services March 30 announced that C2C Innovative Solutions will replace Maximus in reviewing and processing appeals of adverse organization determinations and reconsiderations made by Medicare Advantage plans as of May 1. Maximum will continue to process appeals requests received on or before April 30. CMS said there will be a short period when both Maximus and C2C are issuing decisions. Updates on procedures for submitting appeal case files and other communications will become available on C2C’s website beginning April 1.” 
  • The Wall Street Journal informs us,
    • “The latest Census Bureau data show the broad effects of a big immigration slowdown in the U.S., and a lot more.
    • “The numbers for the year through June 2025 also show fewer people bailing on America’s tech epicenter, a modest Midwest rebound and rising appeal for small southern metros.” 

From the Food and Drug Administration front,

  • In the biggest healthcare news of the day, the Wall Street Journal reports,
    • “The weight-loss pill wars start now. 
    • “Eli Lilly’s once-daily pill for weight loss got approval from U.S. drug regulators Wednesday. The all-clear sets up a battle with rival Novo Nordisk, which has been selling a pill version of its Wegovy since the start of this year.
    • “The Wegovy pill has had one of the best drug launches in history. Now that the Food and Drug Administration has approved its pill, Lilly will seek to overtake the rival, and further its dominance of the booming $70 billion-plus market for weight-loss and diabetes drugs known as GLP-1s.
    • “It will be a battle royal for GLP-1 pill leadership between Novo and Lilly,” Leerink Partners analyst David Risinger said.
    • “Lilly has won a weight-loss fight before: While Novo Nordisk pioneered the use of GLP-1 drugs for weight loss with its Wegovy and Ozempic weekly injections, Lilly’s Zepbound and Mounjaro injections now outsell them.
    • “Yet Novo Nordisk plans to avoid the mistakes that hurt it during the last round, and will seek to hold on to its early lead by emphasizing the effectiveness of its pill.
    • “Analysts are betting on Lilly, expecting its pill, named Foundayo, to generate about $21 billion in global sales by 2030, compared with $4 billion for the Wegovy pill, according to pharmaceutical commercial intelligence firm Evaluate.”
  • Fierce Pharma relates,
    • “The FDA has delayed its target decision date for Orca Bio’s blood cancer cell therapy candidate Orca-T by three months to July 6.
    • “The review extension comes after the company submitted additional data related to chemistry, manufacturing and controls (CMC) a couple of weeks ago upon request by the agency, Orca Bio’s CEO Nate Fernhoff, Ph.D., told Fierce.
    • “Fernhoff wouldn’t specify the exact nature of the FDA’s questions but said the company doesn’t believe “any of these to be fundamental or unaddressable.”
  • MedTech Dive tells us,
    • “Distalmotion has submitted a 510(k) application to expand the label of its Dexter robotic surgery system in the U.S., the company said Wednesday.
    • “The company aims to expand use of Dexter in gynecological indications, strengthening its push to support ambulatory surgical centers that want to perform more outpatient procedures.  
    • “Distalmotion has identified ASCs, which may have less space, resources and infrastructure than hospitals, as sites of care where Dexter could have an advantage over existing surgical robots.”
  • Cardiovascular News informs us,
    • “The U.S. Food and Drug Administration (FDA) has confirmed a new recall of the purge cassettes sold with certain Johnson & Johnson MedTech Impella heart pumps. The alert covers individually packaged Generation 1 Purge Cassettes as well as the ones sold with certain Impella RP, Impella 2.5, Impella CP, Impella CP with Smart Assist, Impella 5.0 and Impella 5.5 with Smart Assist heart pumps. 
    • “The FDA issued this recall due to a risk of the purge cassettes leaking. Purge cassettes play a critical role in patient care, delivering a rinsing fluid to the catheter that prevents blood from flowing back into the motor.
    • “A purge leak may lead to low purge pressure if it goes unaddressed,” according to Johnson & Johnson MedTech. “This can lead to biomaterial ingress, which may lead to an unexpected pump stop. A pump stop may result in a loss of hemodynamic support and lead to patient death.”
    • “The leaks have been linked to four serious injuries and no deaths.”

From the judicial front,

  • ABHW reports,
    • “The Association for Behavioral Health and Wellness (ABHW), the national voice for payers that manage behavioral health insurance benefits for 200 million people, issued the following statement in response to the Trump Administration’s announcement that they will issue a new proposed rule on the Mental Health Parity and Addiction Equity Act (MHPAEA), including anticipated significant revisions to the provisions of the Rule, as ABHW had requested. The Administration has indicated through court documents that it intends to include this rulemaking on the 2026 Spring Regulatory Agenda, and to issue a notice of proposed rulemaking no later than December 31, 2026.”

From the public health and medical / Rx research front,

  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have identified a novel, highly potent opioid that shows potential as a therapy for both pain and opioid use disorder. In a study published in Nature, the team observed the new drug’s effect in laboratory animals. They showed that it has high pain-relieving effects without causing respiratory depression, tolerance or other indicators of potential for addiction in humans.
    • “Opioid pain medications are essential for medical purposes, but can lead to addiction and overdose,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “Developing a highly effective pain medication without these drawbacks would have enormous public health benefits.”
    • “The team investigated formulations of an understudied class of synthetic opioid compounds, known as nitazenes. Nitazenes selectively engage mu-opioid receptors, primary targets for opioid drugs in the brain and peripheral nervous system. However, nitazenes had been shelved in the 1950s due to their excessive potency. The scientific team revisited this class of compounds with a focus on harnessing their selectivity for the mu opioid receptor and engineering new nitazenes with a safer pharmacological profile.
    • “Our goal was to study the profile, or pharmacology, of these drugs,” said Michael Michaelides, Ph.D., senior author and NIDA investigator. “We wanted to decrease the potency and create a potential therapeutic. What we discovered exceeded our expectations.”
  • STAT News reports,
    • “Few things will give a man as much of an insight into the female body as growing up with sisters. Painful, irregular periods, body hair, skin trouble: Al Barrus, a 43-year-old veteran and communications specialist from New Mexico, heard all about it growing up, the only male of three siblings. He’s also known for a while that one of his sisters had been diagnosed with polycystic ovary syndrome, an endocrinological disorder and leading cause of infertility associated with a range of issues including high androgen levels, insulin resistance, and enlarged ovaries. His other sister, too, had some PCOS symptoms. 
    • “Recently, he’s begun to wonder: Could he have it, too? 
    • “Not exactly PCOS but a “male form.” Where women with PCOS’ levels of androgen are too high, his are too low; rather than hirsutism (excess body hair), he has sparse body and facial hair and began going bald as a teenager. He has other issues similar to the ones that can appear in women with PCOS: high levels of the hormone prolactin, suspected insulin resistance, obesity, mental health struggles.” * * *
    • “It took more than a decade, but at last, there is a name, though it is still tightly under wraps “pending submission to a journal for publication,” said Robert Norman, a professor emeritus of reproductive and periconceptual medicine at Adelaide University and one of the experts who worked on selecting a new name. He declined an interview request: “I think you would find it frustrating talking with us when we are not going to reveal the new name yet!” 
  • The American Hospital Association News relates,
    • “The Centers for Disease Control and Prevention has temporarily paused rabies and pox virus testing, according to an update on its website March 30. The pox virus family consists of several viruses, including smallpox and mpox. The CDC typically confirms infections for rabies and pox viruses, among several other infectious diseases.”
  • MedPage Today tells us,
    • “Significant incidental findings detected on low-dose CT lung cancer screening were associated with an increased risk of an extrapulmonary cancer diagnosis over the following year.
    • “Risk differences were significantly higher for urinary cancers, as well as lymphoma and leukemia.
    • “Certain significant incidental findings should be assessed as potential indicators of undiagnosed cancers, researchers said.”
  • Healio informs us,
    • “Incidence of fractures among women begins to rise at age 35 years and increases dramatically starting at age 45 years, whereas men have their highest rates of fracture at age 35 to 45 years, according to data from the UK Biobank.
    • “Our findings reveal a previously underrecognized trajectory of increasing fracture risk in women beginning as early as age 35 years old, with a marked acceleration from the mid-40s,” Catherine Rolls, MSc, research associate in the musculoskeletal research unit and translational and applied research group at University of Bristol in the U.K., and colleagues wrote in a study published in Journal of Bone and Mineral Research. “This female-specific pattern resembles the postmenopausal risk profiles traditionally seen in older populations and suggests that skeletal vulnerability begins earlier than often assumed.”
  • Health Day points out,
    • “Teenagers might be known for being night owls, but they’ll be healthier if they can get to bed earlier, a new study says.
    • “Teens who stay up late and sleep the morning away are more likely to eat more and be less physically active, especially when school is in session, researchers report in the April issue of the journal Sleep Health.
    • “Sleep timing — when teens go to bed and wake up — had the biggest influence on sedentary and eating behavior in teens,” senior researcher Julio Fernandez-Mendoza, a professor of psychiatry and behavioral health at Penn State College of Medicine, said in a news release.
    • “It’s something parents need to pay attention to — and protect — during critical developmental years like adolescence,” he said.”
  • Per MedTech Dive,
    • “Medtronic said it will support a new study of its Symplicity Spyral procedure in patients with uncontrolled high blood pressure and multivessel artery disease who are undergoing percutaneous coronary intervention. Global guidelines indicate patients with both conditions need more aggressive hypertension management, the device maker said this weekend at the American College of Cardiology’s annual meeting.
    • “Medtronic’s Symplicity Spyral renal denervation device won Food and Drug Administration approval in late 2023 to treat patients whose high blood pressure cannot be controlled by drugs. The new study, called EMBRACE, will evaluate renal denervation performed in the same procedure as PCI, a treatment to remove plaque buildup and open blocked coronary arteries.
    • “Separately, Medtronic released results from a pooled analysis of the SPYRAL HTN ON and OFF MED trials showing that patients who underwent a renal denervation procedure to improve their blood pressure had a significantly lower rate of hypertensive emergencies (40%) at three years than those who received a sham treatment.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The combination of technology and alternative care options is slowing the growth rate of healthcare spending.
    • “In January, the Centers for Medicare and Medicaid Services said healthcare expenditures rose 7.2%, to $5.3 trillion, in 2024. Healthcare spending accounted for 18% of gross domestic product in 2024, less than the 21.2% the agency projected.
    • “Advances in care delivery, reduced pricing on some treatments and payer restrictions on care utilization drove down spending, according to a recent study by public policy organization Brookings Institute. 
    • “The healthcare spending growth rate relative to GDP from 2010 to 2024 is the lowest in a 14-year period since 1960, the study said. 
    • “While we’re documenting that the healthcare cost curve has bent and we think that there are reasons that it will continue to be bent, it could still bend more,” said Lev Klarnet, one of the study’s authors and a doctoral student in business economics at Harvard University.
    • “Here are three takeaways from the research.
      • Cost sharing, prior authorizations reduce demand
      • Outpatient procedures are saving money, and
      • “Technology is lowering costs by improving health.”
  • and
    • “The Leapfrog Group will expand its rating system for ambulatory surgery centers.
    • “Starting in July, Leapfrog plans to use publicly reported Centers for Medicare and Medicaid Services data to compare safety and quality measures across nearly 4,000 ASCs, similar to how the independent watchdog group rates hospitals, according to a Tuesday news release. 
  • Beckers Payer Issues reminds us,
    • “For the first time, payers must publicly post data on how often they deny prior authorization requests, how quickly they process them and how often denials are overturned on appeal. The first reports are due March 31 under a rule CMS finalized in 2024.” 
  • Fierce Healthcare tells us,
    • “It’s been seven years since the American Medical Association (AMA) launched its Joy in Medicine program to address physician burnout. 
    • “The issue is far from resolved, with burnout peaking during the COVID-19 pandemic. Recent estimates have found that more than half of surgeons are still burned out. Amid pressing financial challenges and as organizations struggle to recruit clinicians, the need for joy in medicine has never been more pressing.
    • “The AMA’s voluntary program is meant to serve as a guide to health systems looking to assess and address their institutions’ levels of burnout. Organizations must apply and it is free to participate. About 1,800 organizations have participated to date.”
  • BioPharma Dive informs us,
    • “Merck and Co. has signed an agreement with California-based Infinimmune to develop multiple antibodies for various disease targets, the companies announced Tuesday.
    • “Per deal terms, Merck could load Infinimmune with up to $838 million in upfront and milestone payments if any of the drug candidates make it into clinical testing and onto the market. Neither company disclosed how much was offered as an upfront payment. Merck will hold exclusive rights to develop and commercialize drugs that are discovered through the collaboration.”
  • Beckers Hospital Review shares “the big bets 20 pharmacy leaders are making right now.”
  • The Wall Street Journal points out,
    • “The nation’s costliest autism therapy provider will shut down by mid-May, the company’s human resources chief said in an email to employees one week after the state of Indiana said it would bar the firm from billing Medicaid.
    • “The autism-therapy provider, Piece by Piece Autism Centers, received $340,000 in Medicaid payments per patient in 2023, the highest level in the country, The Wall Street Journal reported last month in an article examining how some providers had outpaced regulators in their fast-growing businesses.
    • “Once Piece by Piece—which state officials have said abused the taxpayer-funded program for low-income people—closes, its centers will be operated by a rival autism-therapy provider, Applied Behavior Center for Autism, emails show. Applied Behavior Center settled federal civil fraud allegations over billing issues just three years ago without admitting wrongdoing, the Justice Department announced at the time.”

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • OPM Director Scott Kupor created another post in his Secrets of OPM blog today. This post is titled “Trust but verify,” which has always been the FEHBlog’s favorites Reaganism. Director Kupor concludes,
    • “We have a lot of work to do to ensure the federal government can continue to attract all of the skills needed to deliver on our promises to the American people. While “In America we trust,” in federal hiring we will “trust, but verify.”
  • Modern Healthcare informs us,
    • “A bipartisan House bill that lawmakers plan to introduce this week would cap annual Medicare physician reimbursement cuts at 2.5% while giving regulators more leeway to set annual payment updates.
    • “The Provider Reimbursement Stability Act of 2025 is far from the Medicare payment system overhaul doctors have failed to win for years and it does not include a raise for 2027. But the measure would address underlying aspects of the rate-setting process that medical societies say contributed to pay cuts and modest increases in recent years. 
    • “Under the legislation, CMS would gain financial flexibility, could consider medical inflation in narrow circumstances when calculating fees, and would make changes to the base values it uses to set rates and correct errors that the American Medical Association estimates have cost doctors billions.”
  • STAT News tells us,
    • “Sellers of health savings accounts see an opening for expanding their market, and they’re ramping up lobbying efforts to seize the opportunity.
    • “A group of companies and organizations tied to the HSA industry this year formed a nonprofit called the Great American Health Alliance, or GAHA, a riff on Make America Healthy Again, or MAHA. * * *
    • “Members of GAHA include HealthEquity, one of the largest administrators of HSAs, and the American Bankers Association, which represents institutions holding about 90% of HSAs. GAHA is run by brothers Keith Nahigian, who is the group’s president and has worked for multiple GOP presidential campaigns, and Ken Nahigian, who led the Trump transition in 2017 and was health secretary Robert F. Kennedy Jr.’s liaison to senators during his confirmation process.”
  • American Hospital Association News reports,
    • “The Department of Health and Human Services March 31 announced that it is reverting a 2024 reorganization of health IT leadership and services. The dually titled Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT will now restore ONC as a singularly titled office. The HHS Chief Technology Officer, HHS Chief Artificial Intelligence Officer and HHS Chief Data Officer roles and responsibilities will move back under the HHS Office of the Chief Information Officer. HHS said the changes reinforce OCIO’s responsibility for enterprise IT, cybersecurity and data operations, while ONC will focus on health IT policy, standards and certification.”
  • and
    • “The Centers for Medicare & Medicaid Services March 20 released a memorandum reinforcing hospital nutrition service obligations for hospitals. The memo reminds hospitals of the Medicare conditions of participation that require hospitals to ensure menus and diets meet individual patient nutritional needs in accordance with recognized dietary practices. It also asks hospitals to review and revise their food and nutrition service policies, standard menus, therapeutic protocols and other practices to align with the recently released 2025-2030 Dietary Guidelines for Americans. CMS makes several recommendations for hospital inpatient menus, including limiting ultra-processed foods; eliminating sugar-sweetened beverages unless clinically appropriate in limited scenarios; eliminating refined grains and replacing them with 100% whole grains; prioritizing minimally processed protein sources, including plant-based options; and emphasizing vegetables, fruits, legumes, nuts, seeds, seafood and healthy fats.” 
  • The Wall Street Journal adds,
    • “New nutrition guidance from the American Heart Association advises getting protein from plants rather than meat, choosing low-fat or fat-free dairy and using olive, soybean and canola oils instead of beef tallow and butter. 
    • “The recommendations, released Tuesday by the association, contrast with dietary guidelines that the Trump administration introduced earlier this year.
    • “The differences add to disagreements between the federal government and mainstream medical groups on medicine and nutrition advice, after the Health and Human Services Department under Health Secretary Robert F. Kennedy Jr., for instance, sought to dial back vaccine recommendations and President Trump told pregnant women to minimize Tylenol use.
    • * * * “The association’s latest recommendations are mostly unchanged from the guidelines that it released in 2021 and that the federal government had issued before this year.
    • “Like the federal government, the AHA defines a healthy diet as rich in vegetables and fruits and low in added sugars and ultraprocessed foods. 
    • “Dr. Stacey Rosen, AHA’s president, who is a cardiologist and a senior vice president of women’s health at Northwell Health in New York, said the government’s encouragement to eat red meat and full-fat dairy products could hurt people’s health. “It has been shown repeatedly to be a not healthy way to eat,” she said.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “Amgen’s rare disease drug Tavneos is under mounting regulatory scrutiny, with the FDA warning of serious liver injuries, including some fatalities, among patients who received the drug. 
    • “From the drug’s approval in 2021 through October 2024, 76 cases of drug-induced liver injury with “reasonable evidence” of a causal association to Tavneos were reported to the FDA Adverse Event Reporting System (FAERS), according to a Tuesday safety communication.
    • “The medicine is available as an adjunct treatment for severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. But the FDA is looking to change that with a request for Amgen to withdraw the product, which the company has so far resisted.”
  • Reuters relates,
    • “The U.S. Food and Drug Administration has approved a higher dose of Biogen’s (BIIB.O), opens new tab spinal muscular atrophy drug Spinraza, the company said on Monday, after rejecting it last year.
    • “The approval for a potentially ​more effective treatment marks a boost for the U.S. drugmaker battling intensifying competition ​from therapies such as Roche’s (ROPC.S), opens new tab oral drug Evrysdi and Novartis’ (NOVN.S), opens new tab gene therapies ⁠Zolgensma and Itvisma.”
  • Cardiovascular Business tells us,
    • “Anumana, a Massachusetts-based artificial intelligence (AI) company co-founded by nference and Mayo Clinic, has secured U.S. Food and Drug Administration (FDA) clearance for its advanced pulmonary hypertension (PH) algorithm. The algorithm, which previously received the FDA’s breakthrough device designation, was designed to detect signs of PH in standard 12-lead electrocardiograms (ECGs).
    • “PH is a life-threatening condition that can be difficult for care teams to diagnose. It directly impacts the arteries in a patient’s lungs as well as the right side of their heart. While there is no cure, treatments are available once a diagnosis is confirmed. 
    • ‘Anumana’s newly cleared AI model was built with data from more than 250,000 de-identified Mayo Clinic patients. It runs entirely within the care team’s own hospital or health system environment.
    • “According to Anumana, the algorithm was linked to a sensitivity of 73% and specificity of 74.4% in adult patients presenting with dyspnea. A separate study found that it was able to identify more than 85% of patients presenting with pulmonary arterial hypertension as well as 78% of patients presenting with chronic thromboembolic pulmonary hypertension.”
  • and
    • “A new-look embolic protection device for reducing the risk of stroke after transcatheter aortic valve replacement (TAVR) is associated with clinical outcomes comparable to Boston Scientific’s Sentinel Cerebral Protection System, according to new data presented at ACC.26 in New Orleans.
    • “The device in question is the Emboliner Embolic Protection System from California-based Emboline. Features include a double-wall, cylindrical mesh filter made of Nitinol and a self-sealing port that allows devices such as TAVR delivery systems to pass through when necessary. 
    • “The ProtectH2H clinical trial was a head-to-head comparison of the Emboliner and Sentinel devices. It is believed to be the first head-to-head analysis of any two embolic protection devices for TAVR. More than 500 TAVR patients with a mean age of 79 years old were enrolled out of the United States, Germany and Brazil. Patients were excluded if they had experienced a stroke in the previous six months.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention reminds us,
    • “Chronic kidney disease (CKD) affects more than 37 million U.S. adults. That’s more than 1 in 10 people. The risk is even higher for people with diabetes or high blood pressure. Nearly 4 in 10 adults with diabetes and 2 in 10 adults with high blood pressure have CKD. 
    • “Most people with CKD—about 9 in 10—do not know they have it. CKD often has no early symptoms, but simple blood and urine tests can help find it early. Knowing your risk and getting tested could help protect your kidneys.”
  • Avalere Health marks “National Kidney Month with An Outlook in the 2026 Kidney Care Policy, Payment, and Treatment Landscape.”
    • “Evolving kidney transplant regulations, payment reforms, and accelerated innovation in treatments are opening new opportunities across the kidney care landscape.”
  • This week’s issue of NIH Reseach Matters covers the following topics:
    • SuperAgers show unique cell signatures in the brain
      • “Researchers linked neuron creation to exceptional recall and memory in older adults.
      • “Understanding how new neurons are created in adulthood could help lead to interventions that promote healthy aging.”
    • Scientists identify proteins tied to food tolerance
      • “Scientists identified parts of proteins that interact with immune cells and allow mice to tolerate certain foods rather than have an allergic reaction.
      • “The findings enhance our current understanding of food tolerance and may lead to new therapies for people with food allergies.”
    • Using RNA to treat heart attacks
      • “An RNA-based lipid nanoparticle therapy helped the heart recover from a heart attack in animal studies.
      • “The results suggest a new strategy for treating heart attacks and repairing damage to the heart.”
  • MedPage tells us,
    • “Significant incidental findings detected on low-dose CT lung cancer screening were associated with an increased risk of an extrapulmonary cancer diagnosis over the following year.
    • “Risk differences were significantly higher for urinary cancers, as well as lymphoma and leukemia.
    • “Certain significant incidental findings should be assessed as potential indicators of undiagnosed cancers, researchers said.”
  • Healio adds,
    • “MRIs may be a reasonable option for high-risk patients with extremely dense breasts.
    • “A simulation study found MRIs moderately reduced breast cancer mortality in this group but increased rates of false positives.”
  • and
    • “In stable patients without heart failure, discontinuing beta-blockers 1 year after a heart attack was noninferior to continued use for all-cause death, recurrent MI or HF hospitalization, researchers reported. 
    • “The SMART-DECISION trial is the first randomized study to demonstrate the noninferiority of beta-blocker discontinuation in post-MI patients without left ventricular systolic dysfunction or heart failure,” Joo-Yong Hahn, MD, a cardiologist at Samsung Medical Center in Seoul, South Korea, said during a press conference at the American College of Cardiology Scientific Session. The results were simultaneously published in The New England Journal of Medicine.”
  • The Wall Street Journal reports,
    • “AstraZeneca AZN reported mixed results from three late-stage clinical trials of an experimental treatment for a rare metabolic disease, but remains confident the drug can generate annual peak sales of $3 billion to $5 billion.
    • “The U.K. drugmaker expects to be able to launch the medicine, efzimfotase alfa, in more markets than its predecessor treatment, Strensiq, the chief executive of AstraZeneca’s rare-disease unit Alexion, Marc Dunoyer, said in an interview Tuesday. It plans to submit data to regulators as soon as possible, Dunoyer added.
    • “AstraZeneca said the results of the studies support the drug’s potential to transform the treatment of hypophosphatasia, a rare, chronic disease caused by deficient activity of an enzyme that is important for building healthy bones and supporting proper muscle function.”

From the U.S. healthcare business and artificial intelligence front,

  • Modern Healthcare reports,
    • “Kurt Small has been named as president and CEO of CareFirst BlueCross BlueShield, effective May 4. 
    • “Small is the president of Medicaid for Elevance Health. 
    • He will succeed Ja’Ron Bridges, who has been serving as interim president and CEO since Brian Pieninck left the company in September to become president and CEO of GuideWell and its insurer subsidiary Florida Blue, a CareFirst spokesperson said Tuesday. * * *
    • “Bridges will return to his former role as CareFirst’s executive vice president and chief financial officer. 
    • “Small held several leadership roles at Blue Cross and Blue Shield of Minnesota, Highmark and Aetna prior to joining CareFirst, an independent licensee of the Blue Cross Blue Shield Association.”
  • Healthcare Dive adds,
    • “Elevance announced a slate of mid-level executive appointments on Tuesday as the company continues to shuffle its leadership roster to try to combat waning profits.
    • “The insurer named two new executives to its health benefits division, including a new president of government business after the previous president was promoted to lead Elevance’s broader insurance arm.
    • “Carelon, Elevance’s health services division, added four new executives, including its first chief growth and strategy officer as the company seeks to accelerate Carelon’s expansion.”
    • “The appointments are effective immediately.”
  • The Wall Street Journal informs us,
    • “Eli Lilly LLY has agreed to buy clinical-stage company Centessa Pharmaceuticals CNTA for an initial payment of about $6.3 billion in a deal that expands the drugmaker’s neuroscience portfolio and capabilities into sleep medicine.
    • “Eli Lilly on Tuesday said it will pay an initial $38 a share in cash for Centessa, a 38% premium to Monday’s closing price of $27.58 for the U.K.-based company.
    • “Centessa investors will also receive nontransferrable contingent value rights worth up to an additional $9 a share, bringing the total potential deal consideration to about $7.8 billion, or $47 a share.
    • “The deal is slated to close in the third quarter.’
  • Fierce Pharma adds,
    • “Despite a healthy roster of late-stage assets and a revenue turnaround in 2025, it’s no secret that Biogen has been seeking near-term sales drivers ahead of its planned product rollouts later in the decade. 
    • “Now, the company is responding by bulking up in immunology—and paving the way for its future ambitions in kidney diseases—with an M&A play that adds two ongoing launches to its marketed drugs portfolio.
    • “On Tuesday, Biogen unveiled a deal to acquire Apellis Pharmaceuticals for $41 per share in cash, representing a total transaction value of roughly $5.6 billion. For Biogen, the deal grants access to the approved Apellis meds Syfovre for the eye condition geographic atrophy (GA) and Empaveli, approved by the FDA last year in the rare kidney diseases complement 3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).” 
  • The Wall Street Journal notes,
    • “Big drugmakers are pursuing smaller acquisitions, typically under $10 billion, reflecting a more cautious approach to dealmaking.
    • “Deals between $1 billion and $10 billion represent 76% of pharmaceutical transactions by value this year to date.
    • “Companies like Eli Lilly and Biogen are making smaller deals to bolster pipelines and avoid risks associated with large acquisitions.”
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today releaseda Final Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) for IgA nephropathy.
    • “ICER’s report on this therapy was the subject of the February 2026 public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s three independent evidence appraisal committees. 
    • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations“
  • Beckers Hospital Review informs us,
    • “Retail and e-commerce giants are rapidly expanding their presence in pharmacy services, prompting new concerns among hospital and health system leaders about losing ground in patient access and workforce recruitment.
    • “Amazon, for example, is significantly scaling its pharmacy footprint. The company plans to expand its same-day prescription delivery service to 4,500 U.S. cities and towns by the end of 2026 — adding nearly 2,000 new communities as it targets patients affected by pharmacy closures, staffing shortages and transportation barriers.
    • “Walmart is taking a different approach, focusing heavily on its workforce. The retailer recently promoted 3,000 pharmacy technicians into pharmacy operations team lead roles while also increasing pay. Technician wages now average $22 per hour, with some earning as much as $40.50 depending on certification and location. The newly created team lead roles average $28 per hour, with potential earnings up to $42.”
  • and
    • “Novo Nordisk has launched a multimonth subscription program for Wegovy, which claims to offer more predictable, lower pricing for eligible self-pay patients who enroll through select telehealth providers.
    • “The program is currently available through Ro, WeightWatchers and LifeMD. Additional platforms, including Hims & Hers and Sesame, are expected to join, according to a March 31 news release from Novo. Patients can choose three-, six- or 12-month subscriptions, with longer terms offering lower monthly costs.
    • “Under the program, Wegovy injections are priced at $329 per month for a three-month subscription, $299 per month for six months and $249 per month for 12 months — representing savings of up to $1,200 annually. Oral formulations are priced at $289, $269 and $249 per month across the same timeframes, respectively, with savings of up to $600 annually.
    • “The subscription model aims to reduce cost uncertainty and support adherence for patients managing obesity, a chronic condition that requires ongoing care, according to the release.”
  • Healthcare Innovation considers the “Link Between Ambient Scribes and Increased Coding Intensity.”
    • “Allison Oakes, Ph.D., Trilliant’s chief research officer, discusses how AI-enabled documentation may intersect with coding activity.”
    • “According to Trilliant, AI scribing tools have been associated with an increase in high-intensity outpatient billing codes across six health systems.
    • “The increase in higher-intensity billing codes may reflect improved documentation accuracy rather than intentional overbilling.
    • “Enhanced transparency and auditability of AI-driven billing are crucial for detecting potential issues and ensuring fair reimbursement practices.”
  • Radiology Business has a different outlook.
    • “Imaging interpretation times have more than doubled over the course of a decade, according to new Neiman Health Policy Institute research published Tuesday. 
    • “Current workforce shortages in the specialty are being spurred by increasing per-patient demand for imaging, an aging population and the limited supply of radiologists. As hiring challenges persist, there are growing concerns about the impact on patient care, experts write in JACR. 
    • “Researchers recently aimed to assess how turnaround times—or the period between when a scan is performed and a radiologist reads the images—have changed in recent years. They found that the length of this window leapt by 113% between 2014 and 2023, with worsening wait times beginning two years after the COVID-19 pandemic. 
    • “The potential negative clinical impact of growing turnaround time for the interpretation of imaging must be closely monitored, especially if the trend worsens,” study co-author Cindy Yuan, MD, with the Indiana University School of Medicine, said in a statement March 13. “We think these results are an early indicator of a worsening problem. If the sudden change in 2022 reflects that there is no remaining capacity for the radiology workforce to absorb new workload, then continued imaging growth will eventually impact patients.”
  • MedTech Dive points out,
    • “Whoop, the wearable company that sparked a debate on wellness regulations, has raised $575 million.
    • “The series G round values Whoop at $10.1 billion, the company said on Tuesday. Abbott joined as a strategic investor.
    • “Whoop plans to put the funds toward its U.S. and international growth, as well as personalized health features.”
  • Fierce Healthcare relates,
    • “eMed pocketed $200 million in funding to build out its AI agentic platform and offer new models for employers, including programs for GLP-1 medications.
    • “The funding round boosts the company’s valuation to $2 billion. AON Consulting led the round along with prominent investors former NFL player Tom Brady, founding chief wellness officer, Jeff Aronin, founder, chairman and CEO of Paragon Biosciences; Ara Cohen, co-founder and co-managing Member of Knighthead Capital Management; Antonio Gracias, founder and CEO of Valor Equity Partners; Joe Lonsdale, founder and managing partner at 8VC and co-founder of Palantir; R.J. Melman, CEO, Lettuce Entertain You Restaurants; Tom Ricketts, chairman of the Chicago Cubs; and former X CEO and current eMed CEO Linda Yaccarino. 
    • “The company plans to use the fresh capital to support and fund a new capitated model designed to help employers bend the healthcare cost curve. GLP-1 medications are the most requested workplace benefit, yet only one in five companies provide the benefit, according to the company.”

Monday report

David Ermer–ACA, CDC, CMS, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–
  • Happy National Doctors’ Day!
    • “National Doctors’ Day is a nationwide observance dedicated to honoring physicians for their expertise, responsibility, and continued commitment to patient care. Observed annually on March 30, it creates a natural point of recognition for the role doctors play in the health and well-being of individuals, families, and communities, often during critical and life-changing moments.”

From Washington, DC.

  • Roll Call reports,
    • “President Donald Trump wants Congress to nix a two-week recess and return to the Capitol to address the ongoing Department of Homeland Security shutdown, his top spokesperson said Monday.
    • “The president is also encouraging Congress to come back to Washington to permanently fix this problem and to fund and reopen the Department of Homeland Security entirely,” White House press secretary Karoline Leavitt told reporters.”
  • Govexec adds,
    • “Most Transportation Security Administration officers received a paycheck Monday covering four weeks of back wages that were held up by the funding lapse at the Homeland Security Department, a TSA spokesperson said, [due to an Executive Order].
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM), in partnership with the White House, today announced the launch of a new Early Career Talent Network designed to connect emerging professionals with full-time career opportunities across the federal government.
    • “The new network, available at EarlyCareers.gov, will help build a stronger pipeline of talent into critical mission roles across government, including finance, human resources, engineering, project management, and procurement. The initiative supports broader administration efforts to modernize federal hiring and strengthen the next generation of public servants.
    •  “Building a strong pipeline of early-career talent is essential to the future of the federal workforce,” OPM Director Scott Kupor said. “We are making it easier for talented individuals to connect with meaningful careers in public service while helping agencies efficiently identify the talent they need to deliver results for the American people.”
  • OPM Director Scott Kupor made another management-oriented post to his Secrets of OPM blog now available on Substack. The post discusses the Earlycareers.gov initiative.
  • The American Hospital Association News tells us,
    • “Average out-of-pocket premiums for Health Insurance Marketplace enrollees increased $65 per month in 2026 compared to 2025, going from $113 to $178, according to a report released March 27 by the Centers for Medicare & Medicaid Services. The figures represent costs after accounting for the enhanced premium tax credits, which expired at the end of 2025. CMS also found that 40% of 2026 enrollees selected bronze plans, up from 30% in 2025. Silver plan selection dropped from 56% to 43%, while gold plan selection increased from 13% to 17%. Additionally, CMS said 23.1 million consumers selected or re-enrolled in Marketplace coverage for 2026, marking a 5% decrease from 2025.” 
  • Per National Institutes of Health news releases,
    • “The National Institutes of Health (NIH) today has chosen 15 scientific teams from across the nation as cash prize winners for their submissions to a national crowdsourcing challenge designed to generate innovative ideas that integrate diet and nutrition into autoimmune disease research. Winning submissions investigated the effectiveness of dietary interventions; microbiome, immune system and multi-omic approaches; personalized and data-driven predictive nutrition; and community and patient-center research frameworks. 
    • “Autoimmune diseases affect more than 8% of the U.S. population, impacting between 23 and 50 million Americans. Despite the prevalence and significant economic burden of autoimmune diseases, the role of diet and nutrition in this area remains largely underexplored. NIH invited researchers, clinicians, patients, caregivers, advocacy groups, and interdisciplinary teams to submit feasible, scalable approaches to better understand how dietary interventions may influence autoimmune disease onset, progression, flares, and symptom management. 
    • “The challenge, known as the Nutrition for Our Immune System Health (NOURISH): Autoimmunity Challenge and led by NIH’s Office of Autoimmune Disease Research, yielded many highly competitive submissions, and resulted in 15 prize awards, totaling $10,000 to each team. The winners showed thoughtful planning and designs that, with further development, could result in innovative solutions to benefit Americans affected by autoimmune diseases. Each winning entry contributed innovative, scientifically rigorous, and patient-centered ideas to advance the science of autoimmune disease research and care in one of four thematic areas.”
  • and
    • “The National Institutes of Health (NIH) announced that Elisabeth Armstrong, DBe, has been named chief of staff in the NIH Office of the Director.  As chief of staff, Dr. Armstrong will oversee the Office of the Director. She will provide strategic counsel to the NIH Director and other key leaders within NIH, in addition to managing process, operations, and information flows.    
    • “Dr. Armstrong is an outstanding addition to NIH’s leadership team. Her unique background and range of public and private sector experience will help drive positive action and innovation at NIH,” said NIH Director Jay Bhattacharya, M.D., Ph.D.” 

From the Food and Drug Administration front,

  • BioPharma Dive points out five FDA decisions to watch in the second quarter of 2026, which starts on Wednesday.
  • Per Fierce Pharma,
    • “With a second phase 3 win for Tyvaso in idiopathic pulmonary fibrosis (IPF), United Therapeutics is padding the case for an expansion and putting more color on its filing plans with the FDA. 
    • “In the wake of the “overwhelmingly positive” pair of late-stage readouts, multiple analysts are sharing in United’s optimism that Tyvaso (treprostinil) could change the treatment landscape in the lung scarring disease, which is estimated to affect more than 100,000 people in the U.S.” 
  • MedTech Dive reports,
    • “Medtronic has received 510(k) clearance for its Stealth AXiS surgical system for cranial and ear, nose and throat procedures.
    • “The clearances, which Medtronic disclosed Friday, expand the label of a system that combines surgical planning, navigation and robotics to improve surgeons’ workflows.
    • “Medtronic said cranial surgeons can use the system to create patient-specific brain maps, while the benefits for ENT teams include visualization tailored to the sinuses and skull base.”

From the public health and medical / Rx research front,

  • USA Today reports,
    • “A “highly mutated” COVID variant that flew under the radar for years has been detected in a growing number of U.S. states, health officials said this week.
    • “The Centers for Disease Control and Prevention (CDC) said in a March 19 report that it was tracking variant BA.3.2, nicknamed “Cicada,” after routine surveillance noted an increase in U.S. cases. The World Health Organization (WHO) likewise listed the strain on its “variants of monitoring” record, as it has been detected in at least 23 countries.
    • “Cicada still accounts for only a small number of cases in the United States, but has ballooned to represent up to 30% in some European countries. Still, the CDC said its monitoring of the spread “provides valuable information about the potential for this new SARS-CoV-2 lineage to evade immunity from a previous infection or vaccination.” * * *
    • “The CDC’s latest data from Feb. 11 used wastewater collected by its National Wastewater Surveillance System and Stanford University’s WastewaterSCAN Dashboard. A pathogen’s existence and prominence can be measured by testing wastewater samples collected from sources such as sewage, industrial waste and stormwater runoff.
    • “The testing tracked the presence of BA.3.2 in 25 states, including: California, Connecticut, Florida, Hawaii, Idaho, Illinois, Louisiana, Maine, Michigan, Maryland, Massachusetts, Missouri, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Vermont, Virginia and Wyoming.”
  • Stony Brook (NY) Medicine adds,
    • “The Cicada variant (BA.3.2) is a newer Omicron-related subvariant identified through global and U.S. monitoring systems. Like other recent strains, it has evolved with mutations that may influence how easily it spreads and how the immune system responds.” * * *
    • “Overall, while the Cicada variant may contribute to seasonal increases in cases, it does not currently appear to dramatically change the risk landscape.
    • “Health experts say that the BA.3.2 “Cicada” variant doesn’t seem to cause any new or unusual symptoms compared to other Omicron COVID‑19 variants. Right now, health organizations are mostly tracking how the virus spreads and changes, rather than listing new symptoms.”
  • The Wall Street Journal relates,
    • “Measuring cholesterol levels has long been the main way doctors assess the risk of heart disease. Increasingly, people are opting, too, for a simple, relatively affordable test: a coronary artery calcium scan, or CAC.
    • “The tests recently got a boost from influential clinical guidelines issued earlier this month by leading cardiology groups. These guidelines also included, for the first time, recommended levels of LDL—known as low-density lipoprotein or “bad” cholesterol—based on calcium scores from the scans.
    • “Why does this matter to you? The more calcium you have in your heart, the lower your LDL cholesterol should be to help reduce your risk of having a heart attack or stroke. So the scans give doctors and patients a more precise picture of your risk and whether you need to take action.”
  • The American Medical Association lets us know “what doctors wish patients knew about the deadly risk of stroke.”
    • “Every 40 seconds, someone in the U.S. has a stroke, which is a medical emergency that demands swift action. Meanwhile, every three minutes and 14 seconds, someone dies of stroke in this country. Stroke is the fifth leading cause of death in the U.S. and a major cause of long-term disability for adults, but it is preventable and treatable. That is why patients and families need to know more about preventing and identifying stroke. 
    • “More than 795,000 people in the U.S. have a stroke every year. About 610,000 of these are first or new strokes. Meanwhile, nearly 25% of strokes are in people who have had a previous stroke. And about 87% are ischemic strokes in which blood flow to the brain is blocked, according to the Centers for Disease Control and Prevention (CDC).”
  • Health Day tells us,
    • “For parents of a child with obesity, a normal lab report from the pediatrician may suggest that their weight isn’t yet a problem.
    • “But even if the child’s blood pressure is steady and their sugar levels are fine, those encouraging results — called metabolically healthy obesity or MHO — might be a deceptive snapshot of a much riskier future.
    • ‘Researchers at the Karolinska Institute in Sweden followed more than 7,200 children aged 7 to 17 who were in treatment for obesity. They were followed until age 30. 
    • “Over that period, researchers compared those with metabolically healthy test results to those with early warning signs, and to a control group of more than 35,000 from the general population.
    • ‘The study published March 23 in JAMA Pediatrics found that even kids with MHO — meaning they had normal blood pressure, liver values and blood fats — were at a disadvantage compared to their peers over the long term.”
  • CNN informs us,
    • “Calls to poison centers in the United States about the widely available herb kratom increased more than 1,200% between 2015 and 2025, new research has found.
    • “This data reflects a concerning trend,” study coauthor Dr. Christopher Holstege , director of the Blue Ridge Poison Center at the University of Virginia, said in a news release.
    • “The research was published Thursday in the US Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
    • “Kratom is an herb from the leaves of the tropical tree Mitragyna speciosa native to Southeast Asia. It has both stimulant and sedative effects and carries a risk of addiction due to how it interacts with the brain, Dr. Oliver Grundmann , a leading kratom researcher and clinical professor in the department of medicinal chemistry at the University of Florida, told CNN in an August story.
    • “The psychoactive herb isn’t federally regulated and thus isn’t “lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food,” according to the US Food and Drug Administration. But in states that haven’t banned kratom, it’s sold at gas stations, smoke shops and convenience, grocery and health food stores in various forms, including powders, loose-leaf teas, capsules, tablets and concentrates. Some states allow people of any age to buy it.”
  • Neurology Advisor notes,
    • “Among multiple healthy dietary patterns, higher adherence to the DASH diet was associated with the greatest reduction in risk for subjective cognitive decline, supporting diet quality as a modifiable factor for cognitive health.”
  • Per Fierce Pharma,
    • “After notching a phase 2 trial win, Idorsia’s insomnia med Quviviq (daridorexant) is one step closer to potentially becoming a first-in-class treatment for children.
    • “The drug, a dual orexin receptor antagonist (DORA), was studied in children with insomnia between the ages of 10 and 17 years old, including those with neurodevelopmental disorders such as autism spectrum disorder and attention-deficit/hyperactivity disorder (ADHD). 
    • “As measured through a two-week polysomnography sleep study, 165 patients who received a 10-, 25- or 50-mg dose of Quviviq experienced dose-dependent improvements in total sleep time from baseline, Idorsia reported on Monday.”
  • Per MedTech Dive,
    • “Boston Scientific’s Watchman FLX left atrial appendage closure device worked as effectively as blood thinners to lower stroke risk and death at three years in patients with non-valvular atrial fibrillation, study data unveiled Saturday showed.
    • “The study also demonstrated a 45% relative reduction in non-procedural bleeding risk in patients who received the Watchman FLX implant. The findings of the closely watched CHAMPION-AF clinical trial were presented at the American College of Cardiology’s annual meeting and published in the New England Journal of Medicine.
    • “The 3,000-patient study met all of its safety and efficacy endpoints. Boston Scientific said it will seek to expand the indication and Medicare coverage for the device as a first-line stroke risk reduction option based on the results.

From the U.S. healthcare business and artificial intelligence front,

  • Beckers Hospital Review reports,
    • “Cigna’s Express Scripts continued its lead in the U.S. pharmacy benefit manager market for the second year in a row, processing nearly one-third of all prescription claims, according to a March 30 report from the Drug Channels Institute.
    • “The PBM handled 31% of total equivalent prescription claims last year, up from 30% in 2024. CVS Caremark, which dominated the sector until 2024, saw its share fall to 26% amid volume losses tied to major client transitions. Optum Rx, a subsidiary of UnitedHealth Group, maintained a 23% share for the second straight year.
    • “Despite ongoing scrutiny from regulators and rising competition from smaller firms, the same three PBMs as last year still control 80% of the market.
    • “The rankings are based on Drug Channels Institute’s analysis of total equivalent prescription claims processed across the industry.”
  • and
    • “CVS Pharmacy will open its first pharmacy-only location in Chicago on March 30.
    • “The store, located at 2628 W. Pershing Road in the city’s West End, is part of a planned rollout of nearly 20 pharmacy-only, apothecary-style CVS Pharmacy locations expected to launch in select communities in 2026, according to a March 24 statement from CVS shared with Becker’s. The format reflects CVS’ shift toward smaller, pharmacy-focused stores amid declining retail sales.
    • “CVS is in the early stages of launching the new model, the first locations under which will average less than 5,000 square feet — about half the size of a traditional CVS store. The sites will stock health-related products but exclude general consumer goods like greeting cards and groceries.
    • “The launch comes as CVS repositions its pharmacy footprint. The company closed 270 locations in 2025 but plans to open nearly 100 new sites, including more than 60 acquired from Rite-Aid. According to CVS Health’s October 2025 “Rx Report,” 80% of patients prefer in-person pharmacy care and 84% view pharmacies as credible sources of healthcare. The small-format stores aim to meet these expectations while expanding access in underserved areas.”
  • BioPharma Dive relates,
    • “Obesity drugmaker Kailera Therapeutics plans to test investor appetites for another biotechnology initial public offering, according to a Friday securities filing.
    • “If successful, the company, which has several experimental weight loss medicines in testing, could join a short list of newly public biotechs that have raised more than $1.7 billion in proceeds so far this year.
    • “Kailera’s most advanced prospect, ribupatide, is a weekly GLP-1/GIP agonist in late-stage testing. So far, Kailera and its partner Hengrui Pharma have published data from a 48-week Phase 3 trial in Chinashowing that ribupatide helped people with obesity, on average, lose 18% of their body weight.
    • “The drugmaker expects to publish data from an earlier study of an increased dose next year, and findings from its global Phase 3 study in 2028.”
  • A MedCity News opinion piece explains why
    • “AI Can Expand Access to Healthcare — But Only With Human Action
    • “Health systems can turn insights into action, ensuring that preventive care actually happens by combining accurate risk prediction with human outreach and careful planning.”
  • Per an ICER news release,
    • “The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of lorundrostat (Mineralys Therapeutics, Inc.) and baxdrostat (AstraZeneca) for hypertension.
    • “The assessment will be publicly discussed during a meeting of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in October 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
    • “Consistent with ICER’s process for announcing new assessments, we have spent the past five weeks conducting outreach and engaging with targeted stakeholders, including relevant patient groups, the manufacturers, and clinical experts. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document outlining how we plan to conduct this assessment.  
    • “All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. Comments can be submitted by email to publiccomments@icer.org and must be received by 5 PM ET on April 17, 2026.”

Weekend update

David Ermer–Congress, Federal employment benefits, Generative AI, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Congress left town late last week on two weeklong recess which wraps around the upcoming Passover and Easter holidays.
  • Beckers Payer Issues reports,
    • “Healthcare took center stage in governors’ 2026 “State of the State” addresses.
    • “The National Governors Association compiled excerpts from across the country that focused on healthcare, ranging from technology use to the Rural Health Transformation Program to insurance reforms.”
  • The FEHBlog expects that OPM’s call letter for 2026 FEHB and PSHB benefit and rate proposals will be released this week, and the sooner the better.

From the public health and medical / Rx research front,

  • ABC News reports on how online gambling has become a public health crisis for our Nation’s youth.
    • “[T]he link between gambling early and gambling addiction has become increasingly clear. While only 1% of adults who gamble report addictions, the Journal of Behavioral Addictions reports that between 2% and 7% of young people who place bets report gambling addictions. 
    • “Young people’s brains are particularly susceptible to this because … the parts of their brains that respond to these rewards develop more quickly,” said Dr. Nasir Naqvi, the director of Columbia University’s gambling disorders clinic. “So they become sensitive to these awards and to that dopamine release before the part of their brain that helps them to control these behaviors.” 
    • “Naqvi says he now routinely hears about children as young as 13 seeking support for possible addictions to gambling. 
    • “I don’t want to overstate the problem. But yes … it’s a looming public health crisis,” Naqvi told ABC News. “In fact, it’s already here.” 
  • Medscape reports,
    • “Going into 2026, widespread shortages of most major diabetes medications had largely stabilized: The shortages of Humulin and lispro insulin vials, and therefore medications, that dogged Indianapolis-based Eli Lilly in spring and summer 2024 have resolved, and it, like other manufacturers, has largely caught up with much of the demand for its GLP-1 products as well. 
    • “However, experts from the advocacy group T1D Strong say that shortages of GLP-1 receptor agonists, basal and rapid-acting insulin analogues, and several frontline oral agents are expected to persist into 2026 as the supply chain remains unstable, and especially in certain geographic pockets. 
    • “When shortages occur, it often falls to primary care clinicians to improvise substitutions and bridge strategies, while hospitalists see the downstream effects of shortages in real time in patients who show up with conditions like dehydration, medication errors, and avoidable admissions. The challenge has shifted from simply locating medication to building structured, risk-based strategies that prevent treatment gaps and protect the most vulnerable patients.” “
  • and
    • “Repeating the same meals and keeping calorie intake steady produced more weight loss than eating a more varied diet among individuals living with overweight or obesity, a short-term trial showed.
    • “Conventional wisdom around dieting says you should incorporate a lot of different foods to avoid getting bored and that you should splurge on the weekends or special occasions so you don’t feel as deprived,” lead author Charlotte Hagerman, PhD, of the Oregon Research Institute, Springfield, Oregon, told Medscape Medical News. “This contradicts research showing that consistency makes your behavior more habitual, that is, more automatic or effortless.
    • “We wanted to formally test these competing ideas in a group of people trying to lose weight,” she explained. “Maintaining a healthy diet in today’s food environment requires constant effort and self-control. Creating routines around eating may reduce that burden and make healthy choices feel more automatic.”

From the U.S. healthcare business and articifical intelligence front,

  • Modern Healthcare reports,
    • “Insurers and providers are locked in more messy contract disputes than in previous years
    • “A convergence of economic pressures across nearly all business lines has raised the stakes.
    • “Reimbursement disagreements are just one factor as providers object to insurance company practices.
    • “Both sides are equipped with unprecedented access to price transparency data.”
  • STAT News reports,
    • “Alex Zhavoronkov, CEO of Insilico Medicine, can’t stop complimenting Eli Lilly. “Lilly is better in AI than Insilico, and no other company is better in AI than us … except for these guys,” he said. 
    • “He insisted he wasn’t saying nice things about Lilly just because the pharma giant has signed a new deal with Insilico that’s worth $115 million up front and approximately $2.75 billion in biobucks, which are contingent on achieving regulatory and commercial milestones. After calling Lilly’s tirzepatide, which he is on, “the best drug ever invented by humans,” he said he’s been consistently singing Lilly’s praises for a year. “Mounjaro makes me so happy every day. I want to develop the next one.
    • “It looks like Zhavoronkov might have the opportunity to do just that — his AI drug development company’s new deal with Lilly, announced on Sunday, includes rights for the Mounjaro and Zepbound manufacturer to develop, manufacture, and commercialize some of Insilico’s preclinical AI-discovered candidates for oral therapeutics. Though he declined to say which assets Lilly licensed, he said that the company is the “absolutely best partner” for the candidates and that “nobody is better than them” in these disease areas. Insilico’s pipeline webpage recently was updated to note that a candidate targeting GLP-1 has been out-licensed to an undisclosed partner.” 
  • Beckers Hospital Review relates,
    • “Hospitals and health systems have continued to close maternity units, citing ongoing financial challenges, workforce shortages and declining birth rates. However, in rural Kansas, AdventHealth Ottawa — part of Altamonte Springs, Fla.-based AdventHealth — recently restored labor and delivery services to Franklin County.
    • “The AdventHealth Ottawa Family Birth Place temporarily closed in 2023 and reopened in September 2025 with a fully staffed labor and delivery team. As of August 2025, the hospital had hired 11 full-time staff for the unit, with additional providers joining in 2026.
    • “Maternity care challenges remain significant. A report reflecting data stretching into 2026 from the Center for Healthcare Quality and Payment Reform found that fewer than half of U.S. rural hospitals still offer labor and delivery services. In a dozen states, fewer than one-third do.
    • “Becker’s has reported similar trends, including 29 maternity service closures in 2025 and seven in 2026. Against that backdrop, AdventHealth Ottawa’s reopening stands out.
    • “What’s unique about Ottawa is that we’re an OB desert that does not sit in a population desert, so there’s a lot of population around us that doesn’t have OB services,” AdventHealth Ottawa President and CEO Brendan Johnson said in a hospital video. “But within a large circumference, there’s about 400 to 500 births a year that didn’t have a place to go.”
  • and
    • “Defining return on investment for healthcare technology has never been more consequential — or more contested. As health systems face mounting financial pressure, workforce strain and the rapid proliferation of AI-driven tools, the question of what truly constitutes a return on a technology investment has grown more complex than a simple cost-benefit calculation. The old metrics — uptime, deployment speed, license cost — no longer tell the full story. 
    • ‘”Across the industry, a new framework is emerging, one that measures ROI not just in dollars saved or revenue gained but in time restored to clinicians, cognitive burden lifted, outcomes improved, and trust strengthened between technology and the people who use it. From community hospitals to academic medical centers, health system leaders are redefining what it means for technology to deliver value. Becker’s asked 50 healthcare leaders how they define ROI for a technology they invest in.” [The answers are found in the article.]

Thursday report

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Roll Call reports,
    • “President Donald Trump announced Thursday night he would immediately begin paying Transportation Security Administration workers through an emergency executive order.
    • “The order promised to end long delays at the nation’s airports and allow TSA workers to get paychecks they have been denied during a partial shutdown of the Department of Homeland Security that has persisted for more than 40 days. 
    • “It also offered a partial reprieve for Congress, which has been locked in a bitter partisan standoff over immigration enforcement policies that has kept the department unfunded for weeks. Long lines at airport checkpoints and complaints from TSA workers had become critical pressure points in a search for an end to the shutdown.”
  • Per a White House fact sheet,
    • Today, President Donald J. Trump signed an Executive Order eliminating racially discriminatory “diversity, equity, and inclusion” (DEI) practices by Federal contractors and their subcontractors, ensuring merit-based and efficient contracting and employment.
      • The Order requires that all Federal contracts that are subject to the Federal Property and Administrative Services Act include a clause prohibiting contractors and their subcontractors from engaging in racially discriminatory DEI activities.
      • The Order directs the Office of Management and Budget to issue guidance to contracting agencies to ensure compliance and identify economic sectors that pose a particular risk of engaging in racially discriminatory DEI activities.
      • The Order authorizes contracting agencies to cancel, terminate, or suspend contracts — and to suspend or debar contractors — for failure to comply.
      • The Order directs the Attorney General to prioritize potential claims under the False Claims Act against contractors or subcontractors that are in violation of the contractual terms prohibiting racially discriminatory DEI activities, and ensure the prompt review of related civil actions brought by private persons.
      • The Order directs the Federal Acquisition Regulatory Council to amend Federal Acquisition Regulations to include this clause and remove any conflicting provisions.  
  • Per a CMS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) announced the members of the Healthcare Advisory Committee, a new federal advisory body comprised of leaders from across the healthcare system to provide expert advice on improving, strengthening and modernizing U.S. healthcare.
    • “The Committee will advise HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz on ways to improve how care is financed and delivered across Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace.
    • “This Administration is bringing leaders together to tackle the challenges facing American patients and the health care system, putting prevention front and center,” said HHS Secretary Robert F. Kennedy, Jr. “This committee will help us shift from a sick care system to a true health care system by delivering practical solutions that drive real change.”
    • “We received an overwhelming response from highly qualified candidates across the country,” said CMS Administrator Dr. Mehmet Oz. “These members bring deep expertise across care delivery, financing, innovation, and patient engagement. Their insights will help us advance higher-quality care, reduce administrative burden, and strengthen the sustainability of our programs, while supporting efforts to transform our healthcare system and restore a stronger focus on patients.” * * *
    • “The Committee will convene its first meeting later this year. Additional information, including meeting notices and opportunities for public engagement, will be published in the Federal Register and on the CMS website.
    • “For more information, visit: www.cms.gov/priorities/healthcare-advisory-committee/overview“
  • Federal News Network tells us,
    • “Thrift Savings Plan participation is at an all-time high — and nearly 90% of Federal Employee Retirement System (FERS) participants are contributing enough to receive a full match from the government. The TSP board is also reporting that participant satisfaction with the agency’s customer service center is at nearly 94%. Satisfaction scores have remained at that level, now for more than a year. (Federal Retirement Thrift Investment Board – TSP monthly report, March 2026)”

From the judicial front,

  • Bloomberg Law reports,
    • “The government can lawfully limit federal health carriers from covering certain gender transition procedures, the EEOC said in a new ruling.
    • “The Republican-controlled commission on Thursday rejected claims from a group of transgender current and former federal employees that the Office of Personnel Management’s health coverage policy violated anti-discrimination laws. 
    • “The ruling in Sam T. v. Kupor adds to the Equal Employment Opportunity Commission’s efforts under the Trump administration to chip away at transgender rights in the private and federal sectors.”
  • An OPM news release adds,
    • “The EEOC’s landmark ruling reinforces OPM’s duty to manage the FEHB Program responsibly and protect taxpayer-funded benefits for federal employees and retirees,” Associate Director for Healthcare and Insurance Shane Stevens said. “Federal health benefits must be administered in a way that is fiscally responsible, legally sound, delivers high-quality care, and works toward improved health outcomes.”
  • The next step for this lawsuit is federal district court.
  • The Wall Street Journal relates,
    • “The Justice Department filed an antitrust lawsuit against the prominent hospital system NewYork-Presbyterian, alleging that it used restrictions in its contracts with insurers to limit price competition and block lower-cost healthcare options.
    • “The suit, first reported by The Wall Street Journal, was filed Thursday in the U.S. District Court for the Southern District of New York. It is the latest development in a broader Justice Department effort focused on whether hospital systems use hidden contracts to protect their market position and maintain high prices.”

From the public health and medical / Rx research front.

  • The American Hospital Association News reports,
    • “An American Heart Association study published March 25 found that children born to mothers with premature placental separation could be at higher risk of heart disease by age 28. They also are nearly three times more likely to be hospitalized for heart-related complications, such as heart failure, ischemic heart disease, heart attack, blocked arteries or general cardiovascular disease. The study examined nearly three million pregnancies and found that approximately 1% were impacted by placental abruption. Although limited in scope and not focused on interventions, the study highlights the importance of postpartum and postnatal monitoring for maternal and infant complications.” 
  • The Washington Post points out “five things you need to know about meningitis.”
    • “Two people died in an outbreak of bacterial meningitis in England. The infection, which is rare, requires prompt medical treatment to avoid severe complications.”
  • MedPage Today tells us,
    • “After peaking at over 185,000 courses in 2015, prescriptions for direct-acting antivirals (DAAs) for hepatitis C virus infections dropped 63% by 2025.
    • “While those older than 61 years accounted for over 40% of DAA-treated patients in 2015, that percentage shrank to roughly 25% by 2025.
    • “Specialists wrote two-thirds of DAA prescriptions in 2015, but their share fell to 28% by 2025.” * * *
    • “These are “sobering numbers” that reflect the need for a national HCV elimination plan such as the Cure Hepatitis C Act of 2025, Debika Bhattacharya, MD, of the University of California Los Angeles, told MedPage Today. “We must expand access to DAAs.”
  • and
    • “Patients with a history of depression or anxiety were less likely to see their mental health decline while on GLP-1 medications.
    • “The link between GLP-1 drug use and lower risk of psychiatric decline was more pronounced for semaglutide than for other agents.
    • “The data may allay prior concerns about suicidality, which prompted an FDA investigation in 2023.”
  • and
    • “Alzheimer’s can be detected early with p-tau blood biomarkers, but some tests can lead to overdiagnosis.
    • “Combining p-tau217 and eMTBR-tau243 may refine diagnostic accuracy and reduce false-positives.
    • “Plasma eMTBR-tau243 also could help identify people with high tau burden.”
  • NPR adds,
    • “Babies under 6 months old still have one of the highest rates of hospitalization from COVID-19 infections compared to other age groups, but no COVID vaccine is available for these infants.
    • “That’s one reason the American College of Obstetricians and Gynecologists, or ACOG, recommends COVID vaccination during pregnancy.
    • “There are a number of studies that show one of the benefits of COVID vaccination during pregnancy is the passage of antibodies to the newborn, and then that protects the newborn against COVID,” says Dr. Kevin Ault, a professor of obstetrics and gynecology at Western Michigan University Homer Stryker M.D. School of Medicine in Kalamazoo, Mich.”

From the U.S. healthcare business and artificial intelligence front,

  • MedCity News reports,
    • “Affordability is top of mind for executives at AHIP as Americans battle skyrocketing healthcare costs.
    • “We are laser-focused on affordability at AHIP,” said Mike Tuffin, president and CEO of AHIP. “That’s, of course, the issue at every kitchen table. … We see the cost of hospital care, certainly the cost of brand prescription drugs, specialty care, imaging, down the line, just continuing to rise faster than wages, faster than inflation. That’s driving up premiums across all markets. Premiums directly reflect the underlying cost of medical care.”
    • “Tuffin made these comments during a press briefing on Tuesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C. AHIP is an advocacy organization for health insurers.
    • “As for what’s leading to the rising cost of care, Tuffin pointed the finger at hospital consolidation, as well as actions by drug manufacturers like patent thickets (in which there is a dense web of multiple patents around one medication). 
    • “Tuffin added that AHIP is focused on improving affordability across four zones:
      • “More competition, especially for prescription drugs, and addressing hospital consolidation
      • “Site of service reforms, and increasingly using the home as a site of service. According to Tuffin, too much care is delivered at the costliest sites of care, like the emergency room
      • “Tackling administrative burden, as the healthcare system is still “far too dependent on fax machines”
      • “Aligning incentives around patient care outcomes and driving value across the system.”
  • The Wall Street Journal assesses the “Weight Loss Drug Frenzy: What’s Here and What’s Likely Coming Next.”
    • “The market for weight loss drugs is exploding and patients may have several new options in coming years.”
  • Beckers Payer Issues relates,
    • “Centene has named Kate Casso senior vice president of finance operations and innovation and Theodore Pienkos corporate controller and chief accounting officer.
    • “Ms. Casso has been with Centene for more than two decades and has served as the company’s corporate controller and chief accounting officer since April 2021, according to a March 24 regulatory filing. 
    • “Ms. Casso will focus in part on enterprise and finance innovation while continuing to lead data analytics, medical economics, payment integrity, finance shared services and financial planning and analysis. 
    • “Mr. Pienkos has been with Centene since 2011 and has served as the company’s deputy corporate controller since August 2024. He previously served as vice president of finance and accounting.
    • “Both appointments were effective March 18.”
  • BioPharma Dive informs us,
    • “Merck’s deal for Terns [mentioned in yesterday’s FEHBlog post] sparks debate over a possible biotech bidding war
    • “Some analysts argue the $6.7 billion offer undervalues biotech’s lead cancer drug, although investors may be happy with one-year returns.”
  • and
    • “Shares of Maze Therapeutics, a San Francisco-area biotechnology company, fell over 30% Wednesday despite positive clinical trial results for a progressive kidney disease drug that could potentially compete with a rival therapy from Vertex Pharmaceuticals.
    • “Maze said that, in a mid-stage trial, treatment with its experimental drug, “MZE829,” led to a “clinically meaningful” reduction of protein levels in urine by an average of almost 36% in people with a kidney disease caused by mutations in a gene called APOL1. Maze said it will continue enrollment for its Phase 2 trial and plans to meet with regulators to advance MZE829 into pivotal testing for AMKD, or APOL1-mediated kidney disease.
    • “Full results from the Phase 2 trial will be presented at a future medical conference, Maze added.”
  • Beckers Payer Issues informs us that “UnitedHealthcare has launched Avery, a generative AI companion that helps members navigate healthcare services.”
  • Health Exec adds,
    • “U.S. patients wait an average 31 days to see a doctor, so it’s no wonder 65% of surveyed consumers have consulted AI specifically because it’s faster and easier.
    • “Meanwhile 77% of clinicians appreciate the technology’s contributions to healthcare—yet 1 in 5 patients have tried to hide their use of AI from their doctors. 
    • “Most who admit to the secrecy chalk it up to a fear of being judged. 
    • “The findings are from a survey report released March 24 by Zocdoc, a digital appointment-booking service that has markedly increased its use of AI.”
  • Fierce Healthcare notes,
    • “OpenEvidence released an artificial intelligence-powered medical coding feature embedded in its clinical AI assistant.
    • “The new feature, called Coding Intelligence, provides automatic Current Procedural Terminology (CPT) code suggestions, evaluation and management (E/M) level recommendations with supporting medical decision-making rationale written directly into the note and ICD-10 diagnoses, according to the company.
    • “The tool, available in OpenEvidence Visits, provides coding derived from the clinical documentation and it automatically applies at the end of every doctor-patient visit, executives said.
    • “Without any extra work, OpenEvidence is able to generate concise rationale for their CPT + E/M suggestions. It truly captures the complexity of the encounter and saves me hours when I’m at the ER,” said Ania Bilski, M.D., vice president of clinical AI at OpenEvidence.”

Midweek report

David Ermer–CDC, CMS, Congress, FDA, Government Contracting, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
  • Federal News Network reports,
    • “Following more than a year of sweeping reductions across the federal workforce, Office of Personnel Management Director Scott Kupor told House lawmakers on Wednesday that he would be open to hiring more federal employees — with one crucial caveat.
    • “Kupor said he would be “perfectly happy” to see an increase in federal workforce staffing if it meant that the number of federal contractors went down. The OPM director described contractors as a “shadow” workforce and argued that creating that type of shift would save taxpayer costs and improve government services.
    • “Contractors, I think, can be very valuable where you have temporary assignments, or you have skill gaps where potentially the government can’t recruit those,” Kupor told the House Appropriations Committee’s subcommittee on financial services and general government. “Instead, we have people who are contractors for five, 10, 15, 20 years. They are basically full-time employees in disguise, and they get paid anywhere from 25% to 100% higher than what a federal employee would.”
  • Payment accuracy.gov commends OPM for being one of the three highest performing agencies. OPM’s annual agency financial report for FY 2025 (p. 112) adds the following detail
    • “In FY 2025, FEHB ERC [experience rated carriers, which includes all nationwide plans] activity is reporting a statistically valid improper and unknown payment estimated amount and rate. The ERC activity reports one year in arrears, based on the time necessary to collect, test, report and aggregate the data. Because the ERC activity reports in arrears, PSHB data is not included in the IP estimate being reported in 2025.
    • “Independent public accountants (IPAs) provide the data by conducting sampling, testing and reporting of transactions performed by carriers as required in the Financial Reporting and Audit Guide’s Agreed Upon Procedures.” * * *
    • Based on the results of the sampling and testing for 2024, the FEHB ERCs properly paid 99.86 percent of payments. The FEHB ERCs had an improper and unknown payment rate of 0.14 percent.
  • That information shows that carriers have strong controls over benefit payments.
  • The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the arterial bloodline. The FDA urged customers to use alternate dialysis equipment. The agency provided instructions for users without access to alternate equipment to help mitigate potential harm. B. Braun Medical has not reported any serious injuries or deaths related to the issue as of March 20. 
  • The Wall Street Journal points out,
    • “Indiana is barring Piece by Piece Autism Centers from billing its Medicaid program after a Journal article detailed the company’s practices.
    • “Piece by Piece received the highest per-patient payments in 2023, averaging $340,000, in part by raising list prices up to $640 an hour.
    • “Indiana’s Medicaid director, Mitch Roob, issued an ultimatum to providers to self-report abuses by April 3 or face federal scrutiny.”
  • Modern Healthcare relates,
    • “The Republican congressional majority is weighing further cuts to health programs a year after taking $1 trillion out of the system.
    • “The GOP would use an expedited process called budget reconciliation to prevent Senate Democratic filibusters.
    • ‘The measure could be a vehicle for cuts that didn’t make it into last year’s tax law and for President Donald Trump’s health proposals.
    • “Trump’s demands for Iran war funding and voting restrictions provide the GOP with an opportunity to advance more spending cuts.”
  • Federal News Network further notes,
    • “The U.S. Postal Service is adding a temporary surcharge to most of its standard package shipping options, citing higher fuel and transportation costs.
    • “USPS told its regulatory agency on Wednesday that it plans to implement an 8% across-the-board increase in prices for its core package and shipping services on April 26, and would remain in place until Jan. 17, 2027.
    • “At that time, the Postal Service can determine if a different long-term approach is needed,” USPS said in a press release.
    • “Previously, USPS has only sought limited-time price increases on its package services during its busy holiday peak season, which runs from October through December. But agency officials told the Postal Regulatory Commission that this surcharge is now necessary to account for the higher cost of fuel and contracted transportation services.”
  • Beckers Hospital Review tells us,
    • “The White House has delayed nominating a new CDC director, allowing Jay Bhattacharya, MD, director of the National Institutes of Health, to continue leading the agency past the March 26 deadline, The Washington Post reported March 25.
    • “Dr. Bhattacharya has served as acting CDC director since Feb. 18. Although he will no longer hold that title due to federal rules, he will retain authority over the agency’s delegable duties, an HHS spokesperson told the Post.”

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the arterial bloodline. The FDA urged customers to use alternate dialysis equipment. The agency provided instructions for users without access to alternate equipment to help mitigate potential harm. B. Braun Medical has not reported any serious injuries or deaths related to the issue as of March 20.” 
  • Fierce Pharma relates,
    • “The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease after a string of high-profile rejections for rare disease candidates.
    • “In approving Denali’s tividenofusp alfa, now known as Avlayah, the FDA has greenlit the first treatment for Hunter syndrome that can address the condition’s pernicious cognitive symptoms. 
    • “Avlayah is the first product approved to address neurologic complications of Hunter syndrome,” Tracy Beth Høeg, M.D., Ph.D., acting director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a March 25 release. “This accelerated approval was based on a surrogate endpoint: reduction of cerebrospinal fluid heparan sulfate, which the review team determined was reasonably likely to predict Avlayah’s clinical benefit.”
  • and
    • “With a new U.S. green light in certain ovarian cancer patients, Corcept Therapeutics has redeemed its lead asset relacorilant after stumbling at the finish line in a separate indication late last year. 
    • “The FDA has given the all-clear to Corcept’s class-first selective glucocorticoid receptor antagonist (SGRA) to treat adults with platinum-resistant ovarian cancer. Patients must have tried one to three prior lines of systemic treatment, at least one of which had to include bevacizumab (Avastin). 
    • “The FDA approval covers a regimen of relacorilant, to be sold as Lifyorli, alongside the chemotherapy nab-paclitaxel (Abraxane), according to a March 25 press release. The drug is taken orally the day before, of and after treatment with the regimen’s chemotherapy component, Corcept explained.” “

From the public health and medical / Rx research front,

  • Infectious Disease Advisor relates,
    • “The high rate of persistent physical and psychosocial sequelae of mpox suggests clinicians should consider screening affected individuals for symptoms of depression as well as social and occupational disruptions following acute illness.”
  • Health Day adds,
    • “New fathers might be proud poppas, but their mental health might be shaky as they adapt to their increased responsibilities, a new study says.
    • “Men have a 30% increased risk of depression and stress disorders by the end of their first year of fatherhood, researchers reported March 23 in JAMA Network Open.
    • “This follows a mental health boost among men during pregnancy and the first few months following birth, researchers found.”
  • Healio tells us,
    • “Limiting sedentary time and increasing light-intensity physical activity may reduce risk for developing a hypertensive disorder of pregnancy, according to study findings.
    • “Clinicians should consider counseling pregnant patients not only about exercise, but also about their everyday movement patterns. Based on our findings, limiting sedentary time to no more than 10 hours per day, and ideally closer to 8 hours, may help reduce the risk of developing a hypertensive disorder of pregnancy. Encouraging frequent light-intensity movement throughout the day appears to be an important and achievable target for improving pregnancy health,” Kara M. Whitaker, PhD, MPH, FAHA, associate professor in the department of health, sport and human physiology at University of Iowa, told Healio.”
  • Pharmacy Time adds,
    • “Compositional modeling of sedentary time, light activity, moderate-to-vigorous physical activity (MVPA), and sleep quantified insulin-resistance impacts of time reallocation while adjusting for sociodemographic and seasonal covariates. 
    • “Replacing 30 sedentary minutes with MVPA correlated with approximately 15% lower the homeostatic model assessment of insulin resistance, a clinically meaningful shift in a validated proxy for type 2 diabetes risk. 
    • “Shifting sedentary time to sleep also improved insulin resistance, supporting sleep duration as a metabolic cotarget alongside physical activity in adolescents.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • Merck MRK has reached a nearly $6 billion cash deal to buy the cancer biotech Terns Pharmaceuticals TERN and its promising leukemia treatment.
    • If it proves to work safely, the experimental drug would give Merck a boost as the company prepares for its top-selling drug, Keytruda, to lose patent protection [in 2028].
    • Under the terms, Merck would pay $53 a share for Terns, Merck said Wednesday. The deal is worth $5.7 billion including the cash that Terns has on hand.” * * *
    • “Merck said it expects the deal to close by the end of June and result in a second-quarter charge of about $5.8 billion, or about $2.35 a share.”
  • MedTech Dive relates,
    • “Thermo Fisher Scientific said Tuesday that it has closed the $8.9 billion takeover of Clario, expanding its capabilities for handling clinical trial endpoint data.
    • “The buyout, which was announced in October, gives Thermo Fisher a platform for capturing and managing safety data, efficacy results and patient-reported outcomes in clinical trials.
    • “Thermo Fisher will integrate Clario’s platform with its existing capabilities for analyzing biological samples to create a high-growth business, CEO Marc Casper said at a recent investor event.”
  • BioPharma Dive informs us,
    • “Sarepta Therapeutics shares jumped 25% Wednesday morning after the company unveiled promising early clinical data for two medicines that it gained rights to through a deal with Arrowhead Pharmaceuticals worth more than $1 billion.
    • “The experimental drugs, dubbed SRP-1001 and SRP-1003, aim to treat two rare, genetic conditions that cause dangerous muscle deterioration. The therapies work by delivering small interfering strands of RNA, or siRNA, into muscle tissue to target the genetic abnormalities.
    • “Results from two Phase 1/2 studies released Wednesday show both medicines achieved high muscle concentrations without severe side effects, according to Sarepta. The company said it also has proof-of-concept data showing these treatments can hit their genetic targets.”

Monday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Sen. Markwayne Mullin (R., Okla.) won confirmation to replace Kristi Noem as the next secretary of the Department of Homeland Security.
    • “The final vote Monday night was 54-45 with Sen. Rand Paul (R., Ky.) voting against him over a personal dispute, and Sens. John Fetterman (D., Pa.) and Martin Heinrich (D., N.M.) breaking with all other Democrats to support the Trump nominee.” * * *
    • “Mullin will inherit a department that has been shut down for more than a month over Democrats’ concerns about Immigration and Customs Enforcement’s tactics. Though ICE has continued to operate with money from Republicans’ One Big Beautiful Bill, employees who work other parts of the DHS, such as the Transportation Security Administration, have gone without pay.
    • “Mullin will likely help the administration negotiate with Democrats to reopen his agency. The administration deployed ICE agents to several U.S. airports Monday to help manage long security lines.”
  • Beckers Payer Issues reflects on the 16th anniversary of then President Barack Obama signing the Patient Protection and Affordable Care Act into law.
  • The American Hospital Association News tells us,
    • “The Workgroup for Electronic Data Interchange announced that it is conducting a survey on how health care providers are implementing good faith estimates for uninsured and self-pay individuals under the federal No Surprises Act. The deadline for responses is March 31. WEDI said responses are anonymous and that the data is being collected for informational purposes only.” 
  • Beckers Hospital Review brings us up to date on the prescription drugs available for purchase for cash paying customers on TrumpRx.gov.
  • OPM announced,
    • “The Office of Personnel Management (OPM) withdraws a proposed rule to amend its Freedom of Information Act (FOIA) regulations published on July 24, 2008. [That’s not a typo.] Due to the time that has elapsed, OPM is withdrawing the proposal. OPM will propose amendments to its FOIA regulations in future rulemaking.”

From the Food and Drug Administration front,

  • Fierce Pharm reports,
    • “A common drug combo for Parkinson’s disease will require a new FDA warning after the agency flagged 14 cases of seizures in patients using the medications. 
    • “The agency is mandating (PDF) that drugmakers marketing products incorporating levodopa and carbidopa update their prescribing information to note that the drugs can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures. Healthcare providers should evaluate patients’ baseline vitamin B6 levels prior to and during treatment and supplement patients with the vitamin as necessary, the warning says.
    • “The label update affects Amneal’s Crexont and Rytary; Avion Pharmaceuticals’ Dhivy; Merck’s Sinemet and controlled-release Sinemet CR; Novartis’ Stalevo; and AbbVie’s Duopa. Also affected is AbbVie’s newer Vyalev, a subcutaneous treatment that delivers prodrugs of carbidopa and levodopa via an infusion pump system. Vyalev’s ingredients of foscarbidopa and foslevodopa are drug derivatives of carbidopa and levodopa that become active after entering the body.” 
  • The Wall Street Journal relates,
    • “An experimental Lyme disease vaccine from Pfizer PFE and Valneva VLA didn’t conclusively succeed in a large study, raising questions about the shot’s prospects.
    • “While the shot was more than 70% effective at preventing the tick-borne disease in the trial, not enough people contracted the disease for the findings to be conclusive. Pfizer is pushing ahead with its plans to seek regulatory approval anyway, saying the study hit a different statistical measure and the shot showed “meaningful efficacy.” * * *
    • “The vaccine, if approved, would provide a much-needed addition to the arsenal against Lyme disease. The tick-borne disease has been spreading across the U.S., but there have been few good medical options beyond antibiotics. A vaccine was pulled two decades ago after questions about its safety hurt demand.
    • “No safety concerns were identified in Pfizer and Valneva’s 9,400-person trial. Annaliesa Anderson, Pfizer’s chief vaccines officer, called the study’s results “highly encouraging” and said it “creates confidence in the vaccine’s potential to protect against this disease that can be debilitating.”

From the public health, medical and Rx research front,

  • Cardiovascular Business tells us,
    • “Giving patients tirzepatide early on after an acute myocardial infarction (AMI) or stroke is associated with several benefits, according to new findings published in The American Journal of Cardiology. The study exclusively enrolled patients with no history of diabetes.
    • “Tirzepatide is a popular dual GIP/GLP-1 receptor agonist sold by Lilly under the brand names Zepbound and Mounjaro. It was originally developed for patients with type 2 diabetes. Like other GLP-1 drugs, tirzepatide is starting to be evaluated for more and more uses in patients with and without type 2 diabetes.
    • “Evidence supporting the use of tirzepatide in patients without diabetes, particularly in the early period following AMI or ischemic stroke, is limited,” wrote first author Ibrahim Mortada, MD, a researcher with The University of Texas Medical Branch, and colleagues. “Patients in the post-event setting represent a high-risk population in whom early intervention may modify long-term cardiovascular and cardiorenal outcomes, yet randomized data evaluating tirzepatide for secondary prevention in this context are lacking.”
  • The American Medical Association lets us know what doctors wish their patients knew about social media’s health impact.
  • MedPage Today reports,
    • “A sharp increase in the number of young people hospitalized with eating disorders immediately after the onset of the COVID-19 pandemic was followed by decreases, returning to pre-pandemic levels 5 years later.
    • “The cross-sectional study included 8- to 25-year-olds hospitalized for eating disorders at 41 pediatric hospitals across the U.S.
    • “Further research is needed to understand the increase and the subsequent return to normal.”
  • and
    • “An EEG-derived brain age index predicted dementia risk across five cohorts.
    • “Each 10-year increase in the brain age index was linked with a 39% higher dementia risk.
    • “The findings indicate that the predictive value of the index should be further assessed, the researchers said.”
  • Health Day relates,
    • “Doctors often stop prescribing ADHD stimulants once a patient is diagnosed with a substance use disorder
    • “Treating ADHD in young adults with addiction issues was tied to 30% lower risk of death over five years
    • “Proper ADHD medication led to significantly fewer emergency room visits, hospitalizations and suicidal thoughts.”
  • Genetic Engineering and Biotechnology News points out,
    • “A new Nature Biotechnology paper describes the process of engineering a lab-grown esophagus that can safely replace a full section of the native organ and restore normal functions, including swallowing, in a growing animal without requiring immunosuppression. The paper, which is titled “Functional integration of an autologous engineered esophagus in a large-animal model,” describes “an integrated strategy to engineer a 2.5-cm esophageal segment by microinjecting autologous pericyte-like myogenic precursors and fibroblasts in a decellularized porcine scaffold to repair circumferential defects in 10-kg minipigs … modeling pediatric use.” 
    • “According to scientists from Great Ormond Street Hospital (GOSH) and University College London (UCL) who led the study, their work demonstrates for the first time that a donor pig esophagus can be decellularized, repopulated with the recipient pig’s own cells and implanted in a growing, large-animal model. Other studies have previously shown parts of this technology but this marks the first time that the full process has been completed with this level of success, they said.
    • “Importantly, this development is a major leap towards creating personalized regenerative treatments for children born with life threatening esophageal conditions. Specifically, it could benefit children born with a condition called long-gap esophageal atresia (LGOA). People with this condition have an interrupted esophagus with a wide gap between the upper and lower segments. Patients cannot survive without surgery, but the gap is often too large to close immediately after birth. As a work around, babies with LGOA typically have a feeding tube placed directly into their stomach, so that they can receive adequate nutrition while their hospital teams develop a treatment plan.”

From the U.S. healthcare business and artificial intelligence front,

  • Per a Cigna news release,
    • “Cigna Healthcare, the health benefits division of The Cigna Group (NYSE: CI), today announced that Dr. Stanley Crittenden has joined the organization as Chief Medical Officer. Dr. Crittenden will lead Cigna Healthcare’s clinical organization, advancing initiatives that deliver personalized, high‑quality, affordable care and an exceptional experience for customers and clinicians across the health care system.
    • “Dr. Crittenden will oversee the evolution and implementation of Cigna Healthcare’s clinical solutions and programs, leveraging data and analytics to deliver innovative solutions for clients. Partnering with leaders across The Cigna Group, Dr. Crittenden will help advance the company’s commitments. to providing easier access to care and simplifying the health care experience for customers and physicians.”
  • Fierce Healthcare takes “a look at how Optum Rx is using AI to address pharmacy fraud, waste and abuse.”
  • STAT News reports,
    • “Earlier this year the startup Doctronic launched a provocative, first-in-the-nation experiment to renew drug prescriptions with a chatbot. Now it’s refilling its coffers with $40 million in fresh funding.
    • “Doctronic on Monday announced the Series B investment round led by Abstract and Lightspeed Venture Partners. It has now raised $65 million across three funding rounds in less than a year. The company’s core service uses a chatbot to talk to patients about symptoms and health concerns before transferring them to a clinician over telehealth for diagnosis and treatment, for a $39 fee.  
    • “Doctronic, which describes itself as the world’s most popular AI doctor, plans to use the funding to expand hiring to keep up with growth that has progressed at a breakneck pace. The company was founded in 2023 and only started offering a service with human clinicians in January 2025. Now it’s on track to earn more than $10 million in revenue this year and is preparing to launch versions of its technology with partners, including digital health companies, health systems, and payers.” 
  • MedTech Dive notes,
    • “Labcorp has closed a deal to buy assets from Crouse Health’s pathology reference laboratory, the company said Thursday.
    • “As well as completing the acquisition of assets from Crouse’s Laboratory Alliance of Central New York, Labcorp agreed to manage daily operations at the healthcare provider’s inpatient lab.
    • “Labcorp will assume operation of Lab Alliance’s 12 patient service centers, furthering the testing company’s recent deal-driven push to expand its capabilities in New York.”